HP ERGO, UNKNOWN PEN BODY TYPE
Report
- Report Number
- 1819470-2014-00034
- Event Type
- Injury
- Date Received
- June 10, 2014
- Report Date
- May 15, 2014
- Manufacturer
- ELI LILLY AND COMPANY
- Product Code
- NSC
- PMA / PMN Number
- K982842
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED. THIS REPORT IS ASSOCIATED WITH 1819470-2014-00033, SINCE THERE IS MORE THAN ONE DEVICE IMPLICATED.
SINCE THE DEVICE IS NOT BEING RETURNED, EVALUATION FOR A MALFUNCTION IS NOT POSSIBLE. NARRATIVE FIELD - NEW, UPDATED AND CORRECTED INFORMATION IS REFERENCED WITHIN THE UPDATE STATEMENTS. PLEASE REFER TO UPDATE STATEMENT DATED 25JUN2014. NO FURTHER FOLLOW UP IS PLANNED. THIS REPORT IS ASSOCIATED WITH 1819470-2014-00033, SINCE THERE IS MORE THAN ONE DEVICE IMPLICATED. EVALUATION SUMMARY A FEMALE PATIENT REPORTED THAT WHILE USING HER HUMAPEN ERGO DEVICE SHE EXPERIENCED BOTH HYPERGLYCEMIA AND HYPOGLYCEMIA. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION (BATCH UNKNOWN). THEREFORE, IT COULD NOT BE EVALUATED TO CONFIRM THE COMPLAINT OR PRESENCE OF A MALFUNCTION. MALFUNCTION UNKNOWN. THERE IS EVIDENCE OF IMPROPER USE. THE PATIENT REUSES NEEDLES. THIS MAY BE RELEVANT TO THE COMPLAINT OF HYPERGLYCEMIA
SINCE THE DEVICE IS NOT BEING RETURNED, EVALUATION FOR A MALFUNCTION IS NOT POSSIBLE. NARRATIVE FIELD - NEW, UPDATED AND CORRECTED INFORMATION IS REFERENCED. PLEASE REFER TO UPDATE STATEMENT DATED 24JUL2014. NO FURTHER FOLLOW UP IS PLANNED. THIS REPORT IS ASSOCIATED WITH 1819470-2014-00033, SINCE THERE IS MORE THAN ONE DEVICE IMPLICATED. EVALUATION SUMMARY: A FEMALE PATIENT REPORTED THAT WHILE USING HER HUMAPEN ERGO DEVICE SHE EXPERIENCED BOTH HYPERGLYCEMIA AND HYPOGLYCEMIA. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION (BATCH UNKNOWN). THEREFORE, IT COULD NOT BE EVALUATED TO CONFIRM THE COMPLAINT OR PRESENCE OF A MALFUNCTION. MALFUNCTION UNKNOWN. THERE IS EVIDENCE OF IMPROPER USE. THE PATIENT REUSES NEEDLES. THIS MAY NOT BE RELEVANT TO THE COMPLAINT OF HYPERGLYCEMIA
(B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT LACK OF DRUG EFFECT, CONCERNS A FEMALE PATIENT OF UNKNOWN AGE AND ETHNICITY. THE MEDICAL HISTORY INCLUDED INFARCTION. THE CONCOMITANT MEDICATION INCLUDED METFORMIN INDICATED FOR DIABETES; CARVEDILOL INDICATED FOR PRESSURE (AS REPORTED); AMLODIPINE, LOSARTAN AND HYDROCHLOROTHIAZIDE ALL INDICATED FOR HEART DISORDER (AS REPORTED); OMEPRAZOLE INDICATED FOR CHOLESTEROL (AS REPORTED); GABAPENTIN AND CLONAZEPAM, BOTH INDICATED AS SOOTHE; ASCORBIC ACID, ERGOCALCIFEROL AND IRON ALL WITH UNKNOWN INDICATION FOR USE. THE PATIENT RECEIVED HUMAN INSULIN 30%REGULAR + 70%NPH (HUMULIN 70N/30R) UNKNOWN DOSE, FREQUENCY, SUBCUTANEOUSLY, INDICATED FOR TREATMENT OF TYPE II DIABETES, BEGINNING ON UNSPECIFIED DATE. IT WAS REPORTED THAT THE PATIENT BEGAN HUMAN INSULIN 30%REGULAR + 70%NPH MORE THAN 10 YEARS FROM THE INITIAL REPORT. THE HUMAN INSULIN 30%REGULAR + 70%NPH WAS ADMINISTERED VIA HUMAPEN ERGO UNKNOWN BODY TYPE. IN 2009, THE PATIENT STARTED TO RECEIVE HUMAN INSULIN 30%REGULAR + 70%NPH VIA HUMAPEN ERGO BURGUNDY (BATCH NUMBER (B)(4)). ON UNSPECIFIED DATE, UNKNOWN TIME AFTER STARTING HUMAN INSULIN 30%REGULAR + 70%NPH TREATMENT VIA HUMAPEN ERGO, IT WAS UNCLEAR IF WAS HUMAPEN ERGO UNKNOWN BODY TYPE (BATCH NUMBER UNKNOWN PC ASSOCIATED AS (B)(4)) OR HUMAPEN ERGO BURGUNDY (BATCH NUMBER (B)(4) PC ASSOCIATED AS (B)(4)), THE PATIENT EXPERIENCED HYPOGLYCEMIC EPISODES, REPORTED THAT THE PATIENT WANTED TO VOMIT, LIKE THE PATIENT HAD RETCHING, SHE WAS SWEATING A LOT AND WITH COLD SENSATION. BECAUSE OF THE HYPOGLYCEMIC EPISODES THE PATIENT DISCONTINUED HUMAN INSULIN 30%REGULAR + 70%NPH TREATMENT. ON UNSPECIFIED DATE, REPORTED AFTER TWO YEARS OF HUMAN INSULIN 30%REGULAR + 70%NPH DISCONTINUATION, THE PATIENT RESTARTED HUMAN INSULIN 30%REGULAR + 70%NPH, 20 IN THE MORNING AND 20 AT NIGHT (UNITS NOT PROVIDED), DAILY, SUBCUTANEOUSLY, INDICATED FOR TREATMENT OF TYPE II DIABETES. ON UNSPECIFIED DATE, UNKNOWN TIME AFTER STARTING HUMAN INSULIN 30%REGULAR + 70%NPH VIA HUMAPEN ERGO, IT WAS UNCLEAR IF WAS HUMAPEN ERGO UNKNOWN BODY TYPE OR HUMAPEN ERGO BURGUNDY (BATCH NUMBER (B)(4)), THE PATIENT EXPERIENCED EMOTIONAL DISORDER AND SHE WAS ANGRY. BECAUSE OF EMOTIONAL DISORDER OR WHEN SHE WAS ANGRY, SHE EXPERIENCED EPISODES OF HYPERGLYCEMIA. ON UNSPECIFIED DATE, THE PATIENT HAD DIZZINESS AND HER VISION WAS BLURRED BECAUSE THE BLOOD GLUCOSE OF THE PATIENT RANGED 700 (UNIT NOT PROVIDED) WHEN THE PATIENT WAS VERY ANGRY. THE EVENT BLOOD GLUCOSE RANGED 700 WAS CONSIDERED SERIOUS DUE TO MEDICALLY SIGNIFICANT REASON, BY THE COMPANY. INFORMATION REGARDING CORRECTIVE TREATMENT AND OUTCOME OF EMOTIONAL DISORDER, ANGRY, EPISODES OF HYPERGLYCEMIA WAS NOT PROVIDED. APPROXIMATELY ON (B)(6) 2014, UNKNOWN TIME AFTER RESTARTING HUMAN INSULIN 30% REGULAR +70% NPH TREATMENT VIA HUMAPEN ERGO BURGUNDY (BATCH NUMBER (B)(4)), THE PATIENT STARTED TO URINATE A LOT AND SHE FELT A LOT OF THIRSTY, BECAUSE OF THESE, SHE MEASURED HER BLOOD GLUCOSE, THE BLOOD GLUCOSE WAS 498 (UNIT NOT PROVIDED). ACCORDING TO REPORTER, WHEN THE BLOOD GLUCOSE DECREASED IT WAS 280 OR 300 (UNIT NOT PROVIDED), BUT IT WAS INCREASED QUICKLY. DUE TO BLOOD GLUCOSE HIGH, THE PATIENT BELIEVED THAT THE HUMAN INSULIN 30%REGULAR +70% NPH (BATCH NUMBER (B)(4) PC ASSOCIATED AS (B)(4) AND BATCH NUMBER (B)(4) AND PC ASSOCIATED AS (B)(4)) WAS NOT DOING EFFECT, BECAUSE SHE DID NOT HAD EMOTIONAL STRESS TO HAVE HIGH BLOOD GLUCOSE. AS CORRECTIVE TREATMENT, ON UNSPECIFIED DATE, THE PATIENT INCREASED THE DOSE OF HUMAN INSULIN 30%REGULAR +70% NPH, STARTING TO RECEIVE 30 IN THE MORNING, 20 IN THE AFTERNOON AND 20 AT NIGHT (UNITS NOT PROVIDED), AND SHE REMAINED LYING DURING EPISODE OF BLOOD GLUCOSE HIGH. THE PATIENT RECOVERED FROM SYMPTOMS OF BLOOD GLUCOSE HIGH, BUT SHE DID NOT RECOVER FROM HYPERGLYCEMIA. THE HUMAN INSULIN 30%REGULAR +70% NPH TREATMENT WAS CONTINUED. IT WAS UNKNOWN WHO OPERATED THE DEVICE BUT THE OPERATOR WAS A TRAINED USER. IT WAS UNKNOWN HOW LONG THE DEVICE MODEL WAS USED; THE REPORTED HUMAPEN ERGO UNKNOWN BODY TYPE DURATION OF USE WAS NOT PROVIDED AND THE REPORTED HUMAPEN ERGO BURGUNDY (BATCH NUMBER (B)(4)) WAS USED FOR APPROXIMATELY FIVE YEARS. THE HUMAPEN ERGO UNKNOWN BODY TYPE RETURN WAS NOT RETURNED, AND THE HUMAPEN ERGO BURGUNDY (BATCH NUMBER (B)(4)) RETURN WAS RETURNED ON 29MAY2014. THE REPORTING CONSUMER DID NOT PROVIDE OPINION OF RELATEDNESS BETWEEN THE EVENTS AND HUMAN INSULIN 30%REGULAR +70% NPH TREATMENT, BUT SHE BELIEVED THAT THE EMOTIONAL DISORDER CAUSED HYPERGLYCEMIA. THIS CASE IS CROSS-REFERENCED TO (B)(4). UPDATE 21MAY2014: UPON REVIEW OF THIS CASE ON 21MAY2014, THE CASE WAS OPENED TO UPDATED THE MEDWATCH FIELDS FOR REGULATORY REPORTING. UPDATE 25JUN2014: ADDITIONAL INFORMATION RECEIVED ON 25JUN2014 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY FOR THE HUMAPEN ERGO UNKNOWN BODY TYPE, AND UPDATED THE MEDWATCH AND EU/CA FIELDS. THE RETURN DATE FOR THE HUMAPEN ERGO BURGUNDY WAS ADDED. THE NARRATIVE WAS UPDATED.
(B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT LACK OF DRUG EFFECT, CONCERNS A FEMALE PATIENT OF UNKNOWN AGE AND ETHNICITY. THE MEDICAL HISTORY INCLUDED INFARCTION. THE CONCOMITANT MEDICATION INCLUDED METFORMIN INDICATED FOR DIABETES; CARVEDILOL INDICATED FOR PRESSURE (AS REPORTED); AMLODIPINE, LOSARTAN AND HYDROCHLOROTHIAZIDE ALL INDICATED FOR HEART DISORDER (AS REPORTED); OMEPRAZOLE INDICATED FOR CHOLESTEROL (AS REPORTED); GABAPENTIN AND CLONAZEPAM, BOTH INDICATED AS SOOTHE; ASCORBIC ACID, ERGOCALCIFEROL AND IRON ALL WITH UNKNOWN INDICATION FOR USE. THE PATIENT RECEIVED HUMAN INSULIN 30%REGULAR + 70%NPH (HUMULIN 70N/30R) UNKNOWN DOSE, FREQUENCY, SUBCUTANEOUSLY, INDICATED FOR TREATMENT OF TYPE II DIABETES, BEGINNING ON UNSPECIFIED DATE. IT WAS REPORTED THAT THE PATIENT BEGAN HUMAN INSULIN 30%REGULAR + 70%NPH MORE THAN 10 YEARS FROM THE INITIAL REPORT. THE HUMAN INSULIN 30%REGULAR + 70%NPH WAS ADMINISTERED VIA HUMAPEN ERGO UNKNOWN BODY TYPE. IN 2009, THE PATIENT STARTED TO RECEIVE HUMAN INSULIN 30%REGULAR + 70%NPH VIA HUMAPEN ERGO BURGUNDY (BATCH NUMBER (B)(4)). ON UNSPECIFIED DATE, UNKNOWN TIME AFTER STARTING HUMAN INSULIN 30%REGULAR + 70%NPH TREATMENT VIA HUMAPEN ERGO, IT WAS UNCLEAR IF WAS HUMAPEN ERGO UNKNOWN BODY TYPE (BATCH NUMBER UNKNOWN PC ASSOCIATED AS (B)(4)) OR HUMAPEN ERGO BURGUNDY (BATCH NUMBER (B)(4) PC ASSOCIATED AS (B)(4)), THE PATIENT EXPERIENCED HYPOGLYCEMIC EPISODES, REPORTED THAT THE PATIENT WANTED TO VOMIT, LIKE THE PATIENT HAD RETCHING, SHE WAS SWEATING A LOT AND WITH COLD SENSATION. BECAUSE OF THE HYPOGLYCEMIC EPISODES THE PATIENT DISCONTINUED HUMAN INSULIN 30%REGULAR + 70%NPH TREATMENT. ON UNSPECIFIED DATE, REPORTED AFTER TWO YEARS OF HUMAN INSULIN 30%REGULAR + 70%NPH DISCONTINUATION, THE PATIENT RESTARTED HUMAN INSULIN 30%REGULAR + 70%NPH, 20 IN THE MORNING AND 20 AT NIGHT (UNITS NOT PROVIDED), DAILY, SUBCUTANEOUSLY, INDICATED FOR TREATMENT OF TYPE II DIABETES. ON UNSPECIFIED DATE, UNKNOWN TIME AFTER STARTING HUMAN INSULIN 30%REGULAR + 70%NPH VIA HUMAPEN ERGO, IT WAS UNCLEAR IF WAS HUMAPEN ERGO UNKNOWN BODY TYPE OR HUMAPEN ERGO BURGUNDY (BATCH NUMBER (B)(4)), THE PATIENT EXPERIENCED EMOTIONAL DISORDER AND SHE WAS ANGRY. BECAUSE OF EMOTIONAL DISORDER OR WHEN SHE WAS ANGRY, SHE EXPERIENCED EPISODES OF HYPERGLYCEMIA. ON UNSPECIFIED DATE, THE PATIENT HAD DIZZINESS AND HER VISION WAS BLURRED BECAUSE THE BLOOD GLUCOSE OF THE PATIENT RANGED 700 (UNIT NOT PROVIDED) WHEN THE PATIENT WAS VERY ANGRY. THE EVENT BLOOD GLUCOSE RANGED 700 WAS CONSIDERED SERIOUS DUE TO MEDICALLY SIGNIFICANT REASON, BY THE COMPANY. INFORMATION REGARDING CORRECTIVE TREATMENT AND OUTCOME OF EMOTIONAL DISORDER, ANGRY, EPISODES OF HYPERGLYCEMIA WAS NOT PROVIDED. APPROXIMATELY ON (B)(6) 2014, UNKNOWN TIME AFTER RESTARTING HUMAN INSULIN 30%REGULAR +70% NPH TREATMENT VIA HUMAPEN ERGO BURGUNDY (BATCH NUMBER (B)(4)), THE PATIENT STARTED TO URINATE A LOT AND SHE FELT A LOT OF THIRSTY, BECAUSE OF THESE, SHE MEASURED HER BLOOD GLUCOSE, THE BLOOD GLUCOSE WAS 498 (UNIT NOT PROVIDED). ACCORDING TO REPORTER, WHEN THE BLOOD GLUCOSE DECREASED IT WAS 280 OR 300 (UNIT NOT PROVIDED), BUT IT WAS INCREASED QUICKLY. DUE TO BLOOD GLUCOSE HIGH, THE PATIENT BELIEVED THAT THE HUMAN INSULIN 30%REGULAR +70% NPH (BATCH NUMBER (B)(4) PC ASSOCIATED AS (B)(4) AND BATCH NUMBER (B)(4) AND PC ASSOCIATED AS (B)(4)) WAS NOT DOING EFFECT, BECAUSE SHE DID NOT HAD EMOTIONAL STRESS TO HAVE HIGH BLOOD GLUCOSE. AS CORRECTIVE TREATMENT, ON UNSPECIFIED DATE, THE PATIENT INCREASED THE DOSE OF HUMAN INSULIN 30%REGULAR +70% NPH, STARTING TO RECEIVE 30 IN THE MORNING, 20 IN THE AFTERNOON AND 20 AT NIGHT (UNITS NOT PROVIDED), AND SHE REMAINED LYING DURING EPISODE OF BLOOD GLUCOSE HIGH. THE PATIENT RECOVERED FROM SYMPTOMS OF BLOOD GLUCOSE HIGH, BUT SHE DID NOT RECOVER FROM HYPERGLYCEMIA. THE HUMAN INSULIN 30%REGULAR +70% NPH TREATMENT WAS CONTINUED. IT WAS UNKNOWN WHO OPERATED THE DEVICE BUT THE OPERATOR WAS A TRAINED USER. IT WAS UNKNOWN HOW LONG THE DEVICE MODEL WAS USED; THE REPORTED HUMAPEN ERGO UNKNOWN BODY TYPE DURATION OF USE WAS NOT PROVIDED AND THE REPORTED HUMAPEN ERGO BURGUNDY (BATCH NUMBER (B)(4)) WAS USED FOR APPROXIMATELY FIVE YEARS. THE HUMAPEN ERGO UNKNOWN BODY TYPE RETURN WAS NOT RETURNED, AND THE HUMAPEN ERGO BURGUNDY (BATCH NUMBER (B)(4)) RETURN WAS RETURNED ON 29MAY2014, AND NO MALFUNCTION WAS FOUND. THE REPORTING CONSUMER DID NOT PROVIDE OPINION OF RELATEDNESS BETWEEN THE EVENTS AND HUMAN INSULIN 30%REGULAR +70% NPH TREATMENT, BUT SHE BELIEVED THAT THE EMOTIONAL DISORDER CAUSED HYPERGLYCEMIA. THIS CASE IS CROSS-REFERENCED TO (B)(4). UPDATE 21MAY2014: UPON REVIEW OF THIS CASE ON 21MAY2014, THE CASE WAS OPENED TO UPDATED THE MEDWATCH FIELDS FOR REGULATORY REPORTING. UPDATE 25JUN2014: ADDITIONAL INFORMATION RECEIVED ON 25JUN2014 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY FOR THE HUMAPEN ERGO UNKNOWN BODY TYPE, AND UPDATED THE MEDWATCH AND EU/CA FIELDS. THE RETURN DATE FOR THE HUMAPEN ERGO BURGUNDY WAS ADDED. THE NARRATIVE WAS UPDATED. UPDATE 14JUL2014: ADDITIONAL INFORMATION RECEIVED ON 14JUL2014 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY AND MANUFACTURED DATE OF THE DEVICE; UPDATED THE MALFUNCTION FIELD TO NO; UPDATED THE MEDWATCH AND EU/CA FIELDS; AND UPDATED THE NARRATIVE. UPDATE 24JUL2014. ADDITIONAL INFORMATION RECEIVED 24JUL2014 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE. TO THE DEVICE PAGE UPDATED THE DEVICE SPECIFIC SAFETY SUMMARY (DSSS), THE MEDWATCH FIELDS, AND THE NARRATIVE ACCORDINGLY.
LILLY CASE ID: (B)(6). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT LACK OF DRUG EFFECT, CONCERNS A FEMALE PATIENT OF UNKNOWN AGE AND ETHNICITY. THE MEDICAL HISTORY INCLUDED INFARCTION. THE CONCOMITANT MEDICATION INCLUDED METFORMIN INDICATED FOR DIABETES; CARVEDILOL INDICATED FOR PRESSURE (AS REPORTED); AMLODIPINE, LOSARTAN AND HYDROCHLOROTHIAZIDE ALL INDICATED FOR HEART DISORDER (AS REPORTED); OMEPRAZOLE INDICATED FOR CHOLESTEROL (AS REPORTED); GABAPENTIN AND CLONAZEPAM, BOTH INDICATED AS SOOTHE; ASCORBIC ACID, ERGOCALCIFEROL AND IRON ALL WITH UNKNOWN INDICATION FOR USE. THE PATIENT RECEIVED HUMAN INSULIN 30%REGULAR + 70%NPH (HUMULIN 70N/30R) UNKNOWN DOSE, FREQUENCY, SUBCUTANEOUSLY, INDICATED FOR TREATMENT OF TYPE II DIABETES, BEGINNING ON UNSPECIFIED DATE. IT WAS REPORTED THAT THE PATIENT BEGAN HUMAN INSULIN 30%REGULAR + 70%NPH MORE THAN 10 YEARS FROM THE INITIAL REPORT. THE HUMAN INSULIN 30%REGULAR + 70%NPH WAS ADMINISTERED VIA HUMAPEN ERGO UNKNOWN BODY TYPE. IN 2009, THE PATIENT STARTED TO RECEIVE HUMAN INSULIN 30%REGULAR + 70%NPH VIA HUMAPEN ERGO BURGUNDY (BATCH NUMBER 0607A01). ON UNSPECIFIED DATE, UNKNOWN TIME AFTER STARTING HUMAN INSULIN 30%REGULAR + 70%NPH TREATMENT VIA HUMAPEN ERGO, IT WAS UNCLEAR IF WAS HUMAPEN ERGO UNKNOWN BODY TYPE (BATCH NUMBER UNKNOWN PC ASSOCIATED AS 2979796) OR HUMAPEN ERGO BURGUNDY (BATCH NUMBER 0607A01 PC ASSOCIATED AS 2976544), THE PATIENT EXPERIENCED HYPOGLYCEMIC EPISODES, REPORTED THAT THE PATIENT WANTED TO VOMIT, LIKE THE PATIENT HAD RETCHING, SHE WAS SWEATING A LOT AND WITH COLD SENSATION. BECAUSE OF THE HYPOGLYCEMIC EPISODES THE PATIENT DISCONTINUED HUMAN INSULIN 30%REGULAR + 70% NPH TREATMENT. ON UNSPECIFIED DATE, REPORTED AFTER TWO YEARS OF HUMAN INSULIN 30%REGULAR + 70%NPH DISCONTINUATION, THE PATIENT RESTARTED HUMAN INSULIN 30%REGULAR + 70% NPH, 20 IN THE MORNING AND 20 AT NIGHT (UNITS NOT PROVIDED), DAILY, SUBCUTANEOUSLY, INDICATED FOR TREATMENT OF TYPE II DIABETES. ON UNSPECIFIED DATE, UNKNOWN TIME AFTER STARTING HUMAN INSULIN 30%REGULAR + 70%NPH VIA HUMAPEN ERGO, IT WAS UNCLEAR IF WAS HUMAPEN ERGO UNKNOWN BODY TYPE OR HUMAPEN ERGO BURGUNDY (BATCH NUMBER 0607A01), THE PATIENT EXPERIENCED EMOTIONAL DISORDER AND SHE WAS ANGRY. BECAUSE OF EMOTIONAL DISORDER OR WHEN SHE WAS ANGRY, SHE EXPERIENCED EPISODES OF HYPERGLYCEMIA. ON UNSPECIFIED DATE, THE PATIENT HAD DIZZINESS AND HER VISION WAS BLURRED BECAUSE THE BLOOD GLUCOSE OF THE PATIENT RANGED 700 (UNIT NOT PROVIDED) WHEN THE PATIENT WAS VERY ANGRY. THE EVENT BLOOD GLUCOSE RANGED 700 WAS CONSIDERED SERIOUS DUE TO MEDICALLY SIGNIFICANT REASON, BY THE COMPANY. INFORMATION REGARDING CORRECTIVE TREATMENT AND OUTCOME OF EMOTIONAL DISORDER, ANGRY, EPISODES OF HYPERGLYCEMIA WAS NOT PROVIDED. APPROXIMATELY ON (B)(6) 2014, UNKNOWN TIME AFTER RESTARTING HUMAN INSULIN 30%REGULAR +70% NPH TREATMENT VIA HUMAPEN ERGO BURGUNDY (BATCH NUMBER 0607A01), THE PATIENT STARTED TO URINATE A LOT AND SHE FELT A LOT OF THIRSTY, BECAUSE OF THESE, SHE MEASURED HER BLOOD GLUCOSE, THE BLOOD GLUCOSE WAS 498 (UNIT NOT PROVIDED). ACCORDING TO REPORTER, WHEN THE BLOOD GLUCOSE DECREASED IT WAS 280 OR 300 (UNIT NOT PROVIDED), BUT IT WAS INCREASED QUICKLY. DUE TO BLOOD GLUCOSE HIGH, THE PATIENT BELIEVED THAT THE HUMAN INSULIN 30%REGULAR +70% NPH (BATCH NUMBER C215090C PC ASSOCIATED AS 2976548 AND BATCH NUMBER C185680A AND PC ASSOCIATED AS 2976556) WAS NOT DOING EFFECT, BECAUSE SHE DID NOT HAD EMOTIONAL STRESS TO HAVE HIGH BLOOD GLUCOSE. AS CORRECTIVE TREATMENT, ON UNSPECIFIED DATE, THE PATIENT INCREASED THE DOSE OF HUMAN INSULIN 30%REGULAR +70% NPH, STARTING TO RECEIVE 30 IN THE MORNING, 20 IN THE AFTERNOON AND 20 AT NIGHT (UNITS NOT PROVIDED), AND SHE REMAINED LYING DURING EPISODE OF BLOOD GLUCOSE HIGH. THE PATIENT RECOVERED FROM SYMPTOMS OF BLOOD GLUCOSE HIGH, BUT SHE DID NOT RECOVER FROM HYPERGLYCEMIA. THE HUMAN INSULIN 30%REGULAR +70% NPH TREATMENT WAS CONTINUED. IT WAS UNKNOWN WHO OPERATED THE DEVICE BUT THE OPERATOR WAS A TRAINED USER. IT WAS UNKNOWN HOW LONG THE DEVICE MODEL WAS USED; THE REPORTED HUMAPEN ERGO UNKNOWN BODY TYPE DURATION OF USE WAS NOT PROVIDED AND THE REPORTED HUMAPEN ERGO BURGUNDY (BATCH NUMBER 0607A01) WAS USED FOR APPROXIMATELY FIVE YEARS. THE HUMAPEN ERGO UNKNOWN BODY TYPE RETURN WAS NOT EXPECTED, AND THE HUMAPEN ERGO BURGUNDY (BATCH NUMBER 0607A01) RETURN WAS EXPECTED AND IF THIS DEVICE IS RETURNED, EVALUATION WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS OCCURRED. THE REPORTING CONSUMER DID NOT PROVIDE OPINION OF RELATEDNESS BETWEEN THE EVENTS AND HUMAN INSULIN 30%REGULAR +70% NPH TREATMENT, BUT SHE BELIEVED THAT THE EMOTIONAL DISORDER CAUSED HYPERGLYCEMIA. THIS CASE IS CROSS-REFERENCED TO (B)(4). UPDATE (B)(6) 2014: UPON REVIEW OF THIS CASE ON (B)(6) 2014, THE CASE WAS OPENED TO UPDATED THE MEDWATCH FIELDS FOR REGULATORY REPORTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342386 | HP ERGO, UNKNOWN PEN BODY TYPE | FOR TREATMENT PURPOSES | NSC | ELI LILLY AND COMPANY | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | HIDROCLOROTIAZIDA| CLONAZEPAM| HUMULIN 70N/30R| LOSARTAN| CARDILOL| VITAMIN C| VITAMIN D| AMLODIPIN| FERRO| METFORMINA| OMEPRAZOL| GABAPENTINA |