HUMAPEN ERGO BURGUNDY/CLEAR
Report
- Report Number
- 1819470-2014-00041
- Event Type
- Malfunction
- Date Received
- June 26, 2014
- Report Date
- June 5, 2014
- Manufacturer
- ELI LILLY AND COMPANY
- Product Code
- NSC
- PMA / PMN Number
- K982842
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
EVALUATION SUMMARY: A PATIENT REPORTED THAT HER HUMAPEN ERGO DEVICE WAS "BROKEN" AND "THAT THE CARTRIDGE HOLDER IS NO LONGER ATTACHING TO THE DEVICE BECAUSE THE ENGAGEMENT TABS ARE BROKEN". THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION (BATCH 0612A02, MANUFACTURED DECEMBER 2006). THEREFORE, IT COULD NOT BE EVALUATED TO CONFIRM THE COMPLAINT OR PRESENCE OF A MALFUNCTION. MALFUNCTION UNKNOWN. THE NARRATIVE SUGGESTS THE PRESENCE OF A KNOWN MALFUNCTION (BROKEN CARTRIDGE HOLDER ENGAGEMENT TABS), BUT SINCE THE DEVICE WAS NOT RETURNED, THE MALFUNCTION COULD NOT BE CONFIRMED. A COMPLAINT HISTORY REVIEW OF BATCH 0612A02 REVEALED THERE HAS BEEN NO CONFIRMED CLEAR CARTRIDGE HOLDER TWO TAB BREAKAGE COMPLAINTS. THE USER MANUAL STATES THE FOLLOWING: THE HUMAPEN ERGO HAS BEEN DESIGNED TO BE USED FOR UP TO 3 YEARS AFTER FIRST USE; INSTRUCTS NOT TO USE THE DEVICE IF IT APPEARS BROKEN OR DAMAGED AND TO CONTACT LILLY OR YOUR HEALTHCARE PROFESSIONAL FOR A REPLACEMENT PEN; AND ALWAYS PRIME (CHECK INSULIN FLOW) BEFORE EACH INJECTION. THERE IS EVIDENCE OF IMPROPER USE. BASED ON THE MANUFACTURE DATE, IT IS APPARENT THE PATIENT USED THE DEVICE BEYOND THE RECOMMENDED USE PERIOD. IN ADDITION, THE PATIENT DOES NOT PRIME BEFORE EACH INJECTION.
NEW, UPDATED AND CORRECTED INFORMATION IS REFERENCED WITHIN THE UPDATE STATEMENTS. PLEASE REFER TO UPDATE STATEMENT DATED 26SEP2014. NO FURTHER FOLLOW UP IS PLANNED. EVALUATION SUMMARY: A PATIENT REPORTED THAT HER HUMAPEN ERGO DEVICE WAS BROKEN AND THAT THE CARTRIDGE HOLDER IS NO LONGER ATTACHING TO THE DEVICE BECAUSE THE ENGAGEMENT TABS ARE BROKEN. INVESTIGATION OF THE RETURNED DEVICE (BATCH (B)(4), MANUFACTURED DECEMBER 2006) FOUND THE CLEAR CARTRIDGE HOLDER ENGAGEMENT TABS WERE PRESENT AND INTACT. THE REPORTABLE MALFUNCTION OF A CARTRIDGE HOLDER TWO TAB BREAKAGE WAS NOT CONFIRMED. HOWEVER, THE DEVICE WAS FOUND TO HAVE TWO BROKEN SPRING ARMS WHICH MAY ACCOUNT FOR THE PATIENT'S PERCEPTION OF A LOOSE CARTRIDGE HOLDER. WHEN TESTED, THE DEVICE MET FUNCTIONAL REQUIREMENTS. NO DEVICE MALFUNCTION WAS IDENTIFIED, AND REPORTED ADVERSE EVENT NOT RELATED TO DEVICE USE. A COMPLAINT HISTORY REVIEW OF BATCH (B)(4) REVEALED THERE HAVE BEEN NO CONFIRMED CLEAR CARTRIDGE HOLDER TWO TAB BREAKAGE COMPLAINTS. THE HUMAPEN ERGO 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 TO NOT 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. BASED ON THE MANUFACTURE DATE, IT IS APPARENT THE PATIENT USED THE DEVICE BEYOND THE RECOMMENDED USE PERIOD. IN ADDITION, THE PATIENT DOES NOT PRIME BEFORE EACH INJECTION AND DID NOT HOLD THE INJECTION BUTTON 5 SECONDS.
THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.
LILLY CASE ID: (B)(6). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, CONCERNS A (B)(6) FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATION: HUMAN INSULIN ISOPHANE SUSPENSION FOR UNKNOWN INDICATION FOR USE AND OMEPRAZOLE FOR GASTRIC PROTECTION. THE PATIENT RECEIVED INSULIN LISPRO 50% LISPRO, 50% NPL (HUMALOG MIX 50), CARTRIDGE, VIA HUMAPEN ERGO BURGUNDY/CLEAR, 44 IU, SUBCUTANEOUSLY, TWO TIMES A DAY, FOR THE TREATMENT OF DIABETES TYPE II, BEGINNING OF THE TREATMENT WAS NOT PROVIDED. APPROXIMATELY IN (B)(6) 2004, WHILST ON INSULIN LISPRO 50% LISPRO 50%NPL TREATMENT, THE PATIENT WAS DIAGNOSED WITH HYPOTHYROIDISM. LABORATORY EXAMS WERE NOT PROVIDED. AS CORRECTIVE TREATMENT THE PATIENT RECEIVED LEVOTHYROXINE SODIUM. THE PATIENT DID NOT RECOVER FROM THE EVENT. APPROXIMATELY IN (B)(6) 2013 THE REPORTING CONSUMER STATED THAT THE HUMAPEN ERGO WAS BROKEN. THE CARTRIDGE HOLDER WAS NO LONGER ATTACHING TO THE DEVICE BECAUSE THE ENGAGEMENT TABS WERE BROKEN (PRODUCT COMPLAINT 3002287/ LOT 0612A02). THE PATIENT DID NOT PRIME THE DEVICE WITH EACH USE. INSULIN LISPRO 50%, LISPRO 50% NPL TREATMENT WAS CONTINUED. THE PATIENT WAS THE OPERATOR OF THE DEVICE, IT WAS REPORTED THAT SHE WAS TRAINED. THE AGE OF THIS DEVICE AND HOW LONG THE PATIENT USED THIS DEVICE WAS UNKNOWN (REPORTED AS A LONG TIME). THE DEVICE WAS NOT RETURNED. THE REPORTING CONSUMER DID NOT KNOWN IF THE HYPOTHYROIDISM WAS RELATED WITH INSULIN LISPRO 50%, LISPRO 50% NPL TREATMENT. 03JUL2014 EDIT. UPON INTERNAL REVIEW THE FOLLOWING WERE CORRECTED IN THE NARRATIVE; NPL WAS ADDED TO THE PRODUCT AND CORRECTION TO WORDING OF LENGTH OF USE OF THIS DEVICE. UPDATE 15JUL2014: ADDITIONAL INFORMATION RECEIVED ON 14JUL2014 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY AND MANUFACTURED DATE OF THE DEVICE; ADDED THAT THE DEVICE WAS NOT RETURNED; UPDATED THE MEDWATCH AND EU/CA FIELDS; AND UPDATED THE NARRATIVE.
(B)(4) THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, CONCERNS A (B)(6) FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATION INCLUDED HUMAN INSULIN ISOPHANE SUSPENSION FOR UNKNOWN INDICATION FOR USE AND OMEPRAZOLE FOR GASTRIC PROTECTION. THE PATIENT RECEIVED INSULIN LISPRO 50% LISPRO, 50% NPL (HUMALOG MIX 50), CARTRIDGE, VIA HUMAPEN ERGO BURGUNDY/CLEAR, 44 IU, SUBCUTANEOUSLY, TWO TIMES A DAY, FOR THE TREATMENT OF DIABETES TYPE II, BEGINNING OF THE TREATMENT WAS NOT PROVIDED. APPROXIMATELY IN (B)(6) 2004, WHILST ON INSULIN LISPRO 50% LISPRO 50%NPL TREATMENT, THE PATIENT WAS DIAGNOSED WITH HYPOTHYROIDISM. LABORATORY EXAMS WERE NOT PROVIDED. AS CORRECTIVE TREATMENT THE PATIENT RECEIVED LEVOTHYROXINE SODIUM. THE PATIENT DID NOT RECOVER FROM THE EVENT. APPROXIMATELY IN (B)(6) 2013 THE REPORTING CONSUMER STATED THAT THE HUMAPEN ERGO WAS BROKEN. THE CARTRIDGE HOLDER WAS NO LONGER ATTACHING TO THE DEVICE REPORTEDLY BECAUSE THE ENGAGEMENT TABS WERE BROKEN (PRODUCT (B)(4)/ LOT 0612A02) AND SINCE (B)(6) 2014 THE PATIENT WAS RECEIVING THE INSULIN VIA SYRINGE. THE PATIENT DID NOT PRIME THE DEVICE WITH EACH USE. INSULIN LISPRO 50%, LISPRO 50% NPL TREATMENT WAS CONTINUED. THE PATIENT WAS THE OPERATOR OF THE DEVICE, IT WAS REPORTED THAT SHE WAS TRAINED. THE AGE OF THIS DEVICE AND HOW LONG THE PATIENT USED THIS DEVICE WAS UNKNOWN (REPORTED AS A LONG TIME). THE DEVICE RETURNED ON 11SEP2014. THE REPORTING CONSUMER DID NOT KNOWN IF THE HYPOTHYROIDISM WAS RELATED WITH INSULIN LISPRO 50%, LISPRO 50% NPL TREATMENT. THE 03JUL2014 EDIT. UPON INTERNAL REVIEW THE FOLLOWING WERE CORRECTED IN THE NARRATIVE; NPL WAS ADDED TO THE PRODUCT AND CORRECTION TO WORDING OF LENGTH OF USE OF THIS DEVICE. UPDATE 15JUL2014: ADDITIONAL INFORMATION RECEIVED ON 14JUL2014 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY AND MANUFACTURED DATE OF THE DEVICE; ADDED THAT THE DEVICE WAS NOT RETURNED; UPDATED THE MEDWATCH AND EU/CA FIELDS; AND UPDATED THE NARRATIVE. UPDATE 23SEP2014. ADDITIONAL INFORMATION RECEIVED 23SEP2014 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE DID NOT CONTAIN ANY MEDICALLY SIGNIFICANT INFORMATION. UPDATE 25-SEP-2014. ADDITIONAL INFORMATION RECEIVED FROM INITIAL REPORTING CONSUMER ON 23-SEP-2014 WAS NOT ADDED ANY RELEVANT INFORMATION IN THE CASE. UPDATE 26SEP2014. ADDITIONAL INFORMATION RECEIVED 25SEP2014 FROM THE GLOBAL PRODUCT COMPLAINT SYSTEM. ON DEVICE PAGE ADDED THE PRODUCT RETURN DATE, CHANGED MALFUNCTION TO NO WHICH DELETED THE MALFUNCTION TYPE, DOWNGRADED THE CASE TO NON-SERIOUS, UPDATED THE DEVICE SPECIFIC SAFETY SUMMARY, UPDATED THE EU/CA FIELDS AND UPDATED THE NARRATIVE ACCORDINGLY.
LILLY CASE ID: (B)(6) THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, CONCERNS A (B)(6) YEARS OLD FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATION: HUMAN INSULIN ISOPHANE SUSPENSION FOR UNKNOWN INDICATION FOR USE AND OMEPRAZOLE FOR GASTRIC PROTECTION. THE PATIENT RECEIVED INSULIN LISPRO 50% LISPRO, 50% NPL (HUMALOG MIX 50), CARTRIDGE, VIA HUMAPEN ERGO BURGUNDY/CLEAR, 44 IU, SUBCUTANEOUSLY, TWO TIMES A DAY, FOR THE TREATMENT OF DIABETES TYPE II, BEGINNING OF THE TREATMENT WAS NOT PROVIDED. APPROXIMATELY IN (B)(6) 2004, WHILST ON INSULIN LISPRO 50% LISPRO 50% TREATMENT, THE PATIENT WAS DIAGNOSED WITH HYPOTHYROIDISM. LABORATORY EXAMS WERE NOT PROVIDED. AS CORRECTIVE TREATMENT THE PATIENT RECEIVED LEVOTHYROXINE SODIUM. THE PATIENT DID NOT RECOVER FROM THE EVENT. APPROXIMATELY IN (B)(6) 2013. THE REPORTING CONSUMER STATED THAT THE HUMAPEN ERGO WAS BROKEN. THE CARTRIDGE HOLDER WAS NO LONGER ATTACHING TO THE DEVICE BECAUSE THE ENGAGEMENT TABS WERE BROKEN (PRODUCT COMPLAINT (B)(4)/ LOT 0612A02). THE PATIENT DID NOT PRIME THE DEVICE WITH EACH USE. INSULIN LISPRO 50%, LISPRO 50% TREATMENT WAS CONTINUED. THE PATIENT WAS THE OPERATOR OF THE DEVICE, IT WAS REPORTED THAT SHE WAS TRAINED. IT WAS NOT REPORTED THE DEVICE AGE OR FOR HOW LONG THE PATIENT WAS USING THE SAME DEVICE. THE DEVICE WAS BEING RETURNED. THE REPORTING CONSUMER DID NOT KNOWN IF THE HYPOTHYROIDISM WAS RELATED WITH INSULIN LISPRO 50%, LISPRO 50% TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 373281 | HUMAPEN ERGO BURGUNDY/CLEAR | FOR TREATMENT PURPOSES | NSC | ELI LILLY AND COMPANY | MS8930 | 0612A02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | HUMULIN N| HUMALOG MIX 50 |