HUMAPEN ERGO II
Report
- Report Number
- 1819470-2019-00187
- Event Type
- Injury
- Date Received
- October 14, 2019
- Report Date
- November 20, 2019
- Manufacturer
- ELI LILLY AND COMPANY
- Product Code
- FMF
- PMA / PMN Number
- K151686
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
B.5. NARRATIVE FIELD; NEW UPDATED AND CORRECTED INFORMATION IS REFERENCED WITHIN THE UPDATE STATEMENTS IN B.5. PLEASE REFER TO STATEMENT DATED 29OCT2019 IN THE B.5. FIELD. NO FURTHER FOLLOW UP IS PLANNED. EVALUATION SUMMARY: A MALE PATIENT REPORTED THAT THE INJECTION BUTTON OF HIS HUMAPEN ERGO II DEVICE "WAS PUSHED DOWN TO THE END DIRECTLY WITHOUT CLICKING SOUNDS AND SO THE INSULIN COULD NOT BE PUSHED OUT AND WAS NOT COMING OUT." THE PATIENT EXPERIENCED INCREASED BLOOD GLUCOSE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION (BATCH NUMBER UNKNOWN). THEREFORE, IT COULD NOT BE EVALUATED TO CONFIRM THE COMPLAINT OR PRESENCE OF A MALFUNCTION. MALFUNCTION UNKNOWN. ALL HUMAPEN ERGO II DEVICES ARE ASSESSED FOR INJECTION SCREW TRAVEL AT THE END OF THE MANUFACTURING PROCESS, THUS ENSURING DEVICE FUNCTIONALITY AND DOSE ACCURACY WITH HIGH PROBABILITY. THERE IS NO EVIDENCE OF IMPROPER USE OR STORAGE.
LILLY CASE ID: (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT AN ADVERSE EVENT AND A PRODUCT COMPLAINT (PC), WITH ADDITIONAL INFORMATION FROM THE INITIAL REPORTER, CONCERNS A MALE PATIENT OF AN UNSPECIFIED AGE AND ORIGIN. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30% (RDNA ORIGIN) INJECTION (HUMULIN 70/30), CARTRIDGE VIA A REUSABLE PEN (HUMAPEN ERGO II, COLOR BLUE) 12 UNITS IN THE MORNING AND 12 UNITS AT NIGHT (TWICE DAILY), SUBCUTANEOUSLY FOR THE TREATMENT OF DIABETES MELLITUS TYPE II STARTING SOMETIME BETWEEN 2009 AND 2011 (CONFLICTING INFORMATION). APPROXIMATELY ON (B)(6) 2019 THE INJECTION BUTTON OF THE HUMAPEN ERGO II WAS PUSHED DOWN TO THE END DIRECTLY WITHOUT CLICKING SOUNDS AND SO THE INSULIN COULD NOT BE PUSHED OUT AND WAS NOT COMING OUT OF THE HUMAPEN ERGO II (PC: 4882151/ LOT: UNKNOWN). ON UNSPECIFIED DATES, HE HAD BEEN IN HOSPITAL FOR SEVERAL TIMES WHILE TAKING HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30%. ON AN UNSPECIFIED DATE, HE ATE AND DRANK TOO MUCH; THEREFORE HIS BLOOD GLUCOSE WAS HIGH (NO UNITS OR VALUES PROVIDED) AND CONSEQUENTLY HAD TO BE HOSPITALIZED. HOSPITALIZATION DATES WERE NOT PROVIDED. INFORMATION REGARDING CORRECTIVE TREATMENT AND OUTCOME OF THE EVENT WAS NOT PROVIDED. HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30% TREATMENT WAS ONGOING. THE USER OF THE HUMAPEN ERGO II WAS THE PATIENT AND HIS TRAINING STATUS WAS NOT PROVIDED. THE GENERAL HUMAPEN ERGO II MODEL DURATION OF USE WAS NOT PROVIDED, AND THE REPORTED SUSPECT HUMAPEN ERGO II HAD BEEN IN USE SINCE AN UNSPECIFIED DATE IN 2017. THE ACTION TAKEN FOR THE HUMAPEN ERGO II WAS NOT PROVIDED AND WAS NOT RETURNED TO THE MANUFACTURER. THE REPORTING CONSUMER DID NOT PROVIDE AN ASSESSMENT OF RELATEDNESS BETWEEN EVENT AND HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30% TREATMENT OR HUMAPEN ERGO II DEVICE. UPDATE 20-SEP-2019: THIS CASE WAS CONSIDERED NON-VALID DUE TO NO IDENTIFIABLE VALID ADVERSE EVENT WAS REPORTED, ONLY HOSPITALIZATION WITHOUT FURTHER DETAILS. UPDATE 27-SEP-2019: THIS CASE WAS INITIALLY DETERMINED TO BE NON-VALID (HOSPITALIZATION DESCRIBED ONLY). ADDITIONAL INFORMATION RECEIVED ON 24-SEP-2019 FROM THE INITIAL REPORTER IN RESPONSE TO A FOLLOW-UP THAT CONTAINED VALID ADVERSE EVENT INFORMATION AND THE REASON FOR THE HOSPITALIZATION. CASE WAS UPDATED TO VALID. ADDED THE SERIOUS EVENT OF BLOOD GLUCOSE HIGH AND LABORATORY DATA. UPDATED INDICATION OF HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30% TREATMENT FROM DIABETES MELLITUS TO DIABETES MELLITUS TYPE II, AND HUMAPEN ERGO II DEVICE FROM CONCOMITANT TO SUSPECT. THE NARRATIVE AND FIELDS WERE UPDATED ACCORDINGLY. UPDATE 03-OCT-2019: INFORMATION WAS RECEIVED FROM THE AFFILIATE ON 18-SEP-2019. TR NUMBER WAS RECEIVED AND PC WAS PROCESSED ACCORDINGLY. NO MEDICALLY SIGNIFICANT INFORMATION WAS ADDED TO THE CASE. EDIT 04-OCT-2019: UPON REVIEW, IT WAS ENTERED THE DEVICE AGE ON THE SUSPECT DEVICE TAB. NO OTHER CHANGES PERFORMED OR REQUIRED. EDIT 08OCT2019: UPDATED MEDWATCH FIELDS FOR EXPEDITED DEVICE REPORTING. NO NEW INFORMATION ADDED. UPDATE 10-OCT-2019: ADDITIONAL INFORMATION WAS RECEIVED ON 26-SEP-2019 FROM AFFILIATE. NO MEDICALLY SIGNIFICANT INFORMATION WAS RECEIVED AND NO CHANGES WERE MADE IN THE CASE. UPDATE 29OCT2019: ADDITIONAL INFORMATION RECEIVED ON 28OCT2019 AND 29OCT2019 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE WHICH WERE PROCESSED TOGETHER. ENTERED THE DEVICE SPECIFIC SAFETY SUMMARY (DSSS). UPDATED THE MEDWATCH AND EUROPEAN AND CANADIAN (EU/CA) DEVICE FIELDS FOR THE SUSPECT DEVICE ASSOCIATED WITH PC 4882151. CORRESPONDING FIELDS AND NARRATIVE UPDATED ACCORDINGLY.
IF DEVICE IS RETURNED, EVALUATION WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS OCCURRED. THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.
(B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLIANT: (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT AN ADVERSE EVENT AND A PRODUCT COMPLAINT (PC), WITH ADDITIONAL INFORMATION FROM THE INITIAL REPORTER, CONCERNS A MALE PATIENT OF AN UNSPECIFIED AGE AND ORIGIN. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30% (RDNA ORIGIN) INJECTION (HUMULIN 70/30), CARTRIDGE VIA A REUSABLE PEN (HUMAPEN ERGO II, COLOR BLUE) 12 UNITS IN THE MORNING AND 12 UNITS AT NIGHT (TWICE DAILY), SUBCUTANEOUSLY FOR THE TREATMENT OF DIABETES MELLITUS TYPE II STARTING SOMETIME BETWEEN 2009 AND 2011 (CONFLICTING INFORMATION). APPROXIMATELY ON (B)(6) 2019 THE INJECTION BUTTON OF THE HUMAPEN ERGO II WAS PUSHED DOWN TO THE END DIRECTLY WITHOUT CLICKING SOUNDS AND SO THE INSULIN COULD NOT BE PUSHED OUT AND WAS NOT COMING OUT OF THE HUMAPEN ERGO II (PC: 4882151/ LOT: UNKNOWN). ON UNSPECIFIED DATES, HE HAD BEEN IN HOSPITAL FOR SEVERAL TIMES WHILE TAKING HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30%. ON AN UNSPECIFIED DATE, HE ATE AND DRANK TOO MUCH; THEREFORE HIS BLOOD GLUCOSE WAS HIGH (NO UNITS OR VALUES PROVIDED) AND CONSEQUENTLY HAD TO BE HOSPITALIZED. HOSPITALIZATION DATES WERE NOT PROVIDED. INFORMATION REGARDING CORRECTIVE TREATMENT AND OUTCOME OF THE EVENT WAS NOT PROVIDED. HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30% TREATMENT WAS ONGOING. THE USER OF THE HUMAPEN ERGO II WAS THE PATIENT AND HIS TRAINING STATUS WAS NOT PROVIDED. THE GENERAL HUMAPEN ERGO II MODEL DURATION OF USE WAS NOT PROVIDED, AND THE REPORTED SUSPECT HUMAPEN ERGO II HAD BEEN IN USE SINCE AN UNSPECIFIED DATE IN 2017. THE ACTION TAKEN AND RETURN STATUS OF THE HUMAPEN ERGO II WAS NOT PROVIDED. THE REPORTING CONSUMER DID NOT PROVIDE AN ASSESSMENT OF RELATEDNESS BETWEEN EVENT AND HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30% TREATMENT OR HUMAPEN ERGO II DEVICE. UPDATE 20-SEP-2019: THIS CASE WAS CONSIDERED NON-VALID DUE TO NO IDENTIFIABLE VALID ADVERSE EVENT WAS REPORTED, ONLY HOSPITALIZATION WITHOUT FURTHER DETAILS. UPDATE 27-SEP-2019: THIS CASE WAS INITIALLY DETERMINED TO BE NON-VALID (HOSPITALIZATION DESCRIBED ONLY). ADDITIONAL INFORMATION RECEIVED ON 24-SEP-2019 FROM THE INITIAL REPORTER IN RESPONSE TO A FOLLOW-UP THAT CONTAINED VALID ADVERSE EVENT INFORMATION AND THE REASON FOR THE HOSPITALIZATION. CASE WAS UPDATED TO VALID. ADDED THE SERIOUS EVENT OF BLOOD GLUCOSE HIGH AND LABORATORY DATA. UPDATED INDICATION OF HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30% TREATMENT FROM DIABETES MELLITUS TO DIABETES MELLITUS TYPE II, AND HUMAPEN ERGO II DEVICE FROM CONCOMITANT TO SUSPECT. THE NARRATIVE AND FIELDS WERE UPDATED ACCORDINGLY. UPDATE 03-OCT-2019: INFORMATION WAS RECEIVED FROM THE AFFILIATE ON 18-SEP-2019. TR NUMBER WAS RECEIVED AND PC WAS PROCESSED ACCORDINGLY. NO MEDICALLY SIGNIFICANT INFORMATION WAS ADDED TO THE CASE. EDIT 04-OCT-2019: UPON REVIEW, IT WAS ENTERED THE DEVICE AGE ON THE SUSPECT DEVICE TAB. NO OTHER CHANGES PERFORMED OR REQUIRED. EDIT 08OCT2019: UPDATED MEDWATCH FIELDS FOR EXPEDITED DEVICE REPORTING. NO NEW INFORMATION ADDED. UPDATE 10-OCT-2019: ADDITIONAL INFORMATION WAS RECEIVED ON 26-SEP-2019 FROM AFFILIATE. NO MEDICALLY SIGNIFICANT INFORMATION WAS RECEIVED AND NO CHANGES WERE MADE IN THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 982974 | HUMAPEN ERGO II | FOR TREATMENT PURPOSES | FMF | ELI LILLY AND COMPANY | MS9557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |