HUMAPEN ERGO
Report
- Report Number
- 1819470-2014-00038
- Event Type
- Injury
- Date Received
- June 16, 2014
- Report Date
- April 9, 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
NEW, UPDATED AND CORRECTED INFORMATION IS REFERENCED WITHIN THE UPDATE STATEMENTS. PLEASE REFER TO UPDATE STATEMENT DATED (B)(6) 2014. NO FURTHER FOLLOW UP IS PLANNED. EVALUATION SUMMARY A PATIENT'S MOTHER REPORTED THAT HER DAUGHTER'S HUMAPEN ERGO DEVICE WAS BROKEN. SHE CONTINUED TO USE THE DEVICE AND THOUGHT IT DELIVERED A DOSE LARGER THAN EXPECTED. THE PATIENT EXPERIENCED HYPOGLYCEMIA. INVESTIGATION OF THE RETURNED DEVICE (BATCH (B)(4), MANUFACTURED APRIL 2005) FOUND IT WAS BROKEN (GLUE BOND SEPARATION) AND COULD NOT BE FUNCTION TESTED. WHILE THE EXACT DATE WHEN THE PATIENT STARTED USING THE DEVICE COULD NOT BE DETERMINED, BASED ON THE AMOUNT OF TIME ELAPSED SINCE THIS DEVICE HAD BEEN MANUFACTURED (APRIL 2005) IT IS LIKELY THAT THE PATIENT USED IT BEYOND ITS APPROVED USE LIFE. HUMAPEN ERGO DEVICES WERE LAST MANUFACTURED IN 2006. THE USER MANUAL STATES THE HUMAPEN ERGO HAS BEEN DESIGNED TO BE USED FOR UP TO 3 YEARS AFTER FIRST USE. THE USER MANUAL ALSO INSTRUCTS NOT TO USE THE DEVICE IF IT APPEARS BROKEN OR DAMAGED AND TO CONTACT LILLY OR YOUR HEALTHCARE PROFESSIONAL FOR A REPLACEMENT PEN. THERE IS EVIDENCE OF IMPROPER USE. THE PATIENT USED THE DEVICE WHILE IT WAS BROKEN. ADDITIONALLY, BASED ON THE MANUFACTURE DATE, IT IS LIKELY THAT THE PATIENT USED IT BEYOND ITS APPROVED USE LIFE.
LILLY CASE ID: (B)(6). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT, CONCERNS A (B)(6) YEARS OLD FEMALE PATIENT. THE PATIENT MEDICAL HISTORY INCLUDED: TYPE 1 DIABETES MELLITUS. CONCOMITANT MEDICATIONS INCLUDED: GLARGINE INSULIN FOR UNKNOWN INDICATION FOR USE. THE PATIENT RECEIVED LISPRO INSULIN (HUMALOG) 10 IU AFTER LUNCH AND 10 IU AFTER DINNER, SUBCUTANEOUSLY (IN THE ARM), FOR TYPE 1 DIABETES MELLITUS, BEGINNING APPROXIMATELY IN 2002. IT WAS STATED THAT PATIENT FIRST USED A SYRINGE TO DELIVER THE LISPRO INSULIN, BUT SINCE APPROXIMATELY 2002, THE LISPRO INSULIN WAS DELIVERED VIA HUMAPEN ERGO TEAL/CLEAR (LOT NUMBER 0504A01). IT WAS STATED THE PEN HUMAPEN ERGO TEAL/CLEAR THAT THE PATIENT ADMINISTERED THE LISPRO INSULIN WAS BROKEN, ACCORDING TO THE REPORTER, UNSPECIFIED PART OF THE DEVICE (THE BACK OF THE PEN) CAME OUT AND WAS ON HER HAND. BEFORE EACH INJECTION, THE REPORTER TRIED TO FIT THE PART OF THE PEN CORRECTLY AND MAKE SURE THAT THE PEN WAS INJECTING THE CORRECT DOSE (ASSOCIATED TO PRODUCT COMPLAINT NUMBER (B)(4)). SINCE 2002, SINCE THE BEGINNING OF THE TREATMENT WITH LISPRO INSULIN, PATIENT EXPERIENCED PAIN AND BURNING ON THE INJECTION SITE WHEN HELD LONG TIME THE NEEDLE INTO THE SKIN. APPROXIMATELY IN (B)(6) 2013, THE PATIENT RECEIVED A DOSE OF LISPRO INSULIN BEYOND THE RECOMMENDED, DUE TO THE PROBLEM OF THE DEVICE. IN 2013, APPROXIMATELY 11 YEARS AFTER BEGINNING THE TREATMENT WITH LISPRO INSULIN, THE PATIENT EXPERIENCED BLOOD GLUCOSE DECREASED (UNKNOWN VALUES) AND FAINTED AND DUE TO THESE SHE WAS HOSPITALIZED. IT WAS NOT REPORTED IF PATIENT RECEIVED CORRECTIVE TREATMENT AT HOSPITAL. THE PATIENT WAS HOSPITALIZED PER ONE DAY AND AFTER SHE WAS DISCHARGED FROM HOSPITAL. IT WAS STATED THE PATIENT USED THIS DEVICE MODEL FOR APPROXIMATELY 12 YEARS AND USED IT BROKEN. THE PATIENT DID NOT RECEIVE CORRECTIVE TREATMENT FOR PAIN AT INJECTION SITE, BUT IT WAS NOT REPORTED IF SHE RECEIVED CORRECTIVE TREATMENT FOR BURNING AT INJECTION SITE. FURTHERMORE IT WAS STATED THAT, SINCE UNKNOWN DATE, THE PATIENT RECEIVED A NEW DEVICE AND THEN STARTED TO RECEIVE THE CORRECT DOSE OF INSULIN. THE OUTCOME OF BLOOD GLUCOSE DECREASED AND FAINT WAS NOT PROVIDED AND THE PATIENT DID NOT RECOVER FROM PAIN AND BURNING AT INJECTION SITE. THE LISPRO INSULIN TREATMENT WAS CONTINUED. THE PATIENTS MOTHER WAS THE OPERATOR OF DEVICE AND WAS TRAINED BY AN EDUCATOR MANY YEARS BEFORE THE TIME OF THE REPORT. THE PATIENT HAD USED THIS DEVICE MODEL AND REPORTED DEVICE FOR APPROXIMATELY 12 YEARS. THE DEVICE WAS RETURNED ON (B)(4) 2014. THE REPORTING CONSUMER STATED THAT LOW BLOOD GLUCOSE AND FAINT WAS NOT RELATED WITH LISPRO INSULIN TREATMENT AND IT OCCURRED BECAUSE THE PATIENT DID NOT EAT APPROPRIATELY. ALSO THE REPORTER STATED THAT PAIN AT INJECTION SITE WAS RELATED WITH LISPRO INSULIN AND DID NOT PROVIDE A RELATEDNESS OPINION BETWEEN BURNING AT INJECTION SITE, WRONG DOSE AND LISPRO INSULIN. ADDITIONALLY, THE FACT THAT PATIENT RECEIVED A DOSE OF LISPRO INSULIN BEYOND THE RECOMMENDED OCCURRED DUE TO THE PROBLEM OF THE DEVICE; HOWEVER, NO OTHER OPINION WAS PROVIDED BETWEEN THE OTHER EVENTS AND DEVICE . UPDATE (B)(6) 2014. FOLLOW UP RECEIVED FROM INITIAL REPORTING CONSUMER ON (B)(6) 2014. ADDED SERIOUS EVENTS OF LOW BLOOD GLUCOSE WITH FAINT, INJECTION SITE BURNING AS NON SERIOUS EVENT, ADDED START DATE, CORRECTIVE TREATMENT AND OUTCOME OF PAIN AT INJECTION SITE. ADDED OUTCOME FOR EVENT WRONG DOSE ADMINISTERED. THE AS REPORTED CAUSALITY OF EVENT PAIN AT INJECTION SITE WAS CHANGED TO YES. THE (B)(4) FIELD WAS ADDED. ALL CORRESPONDENTS FIELDS WERE UPDATED. UPDATE (B)(6) 2014: ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY, RETURN DATE OF THE DEVICE, AND MANUFACTURED DATE OF THE DEVICE; UPDATED THE MEDWATCH AND (B)(4) FIELDS; AND UPDATED THE NARRATIVE. EDIT (B)(6) 2014. UPON INTERNAL REVIEW FOR REGULATORY SUBMISSION, THE TIME OF USE OF DEVICE MODEL WAS CORRECTED IN NARRATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352609 | HUMAPEN ERGO | FOR TREATMENT PURPOSES | NSC | ELI LILLY AND COMPANY | MS8929 | 0504A01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Hospitalization | LANTUS| HUMALOG |