BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO 3 ML

    MDR report key: 393188 · Received May 2, 2002

    Report

    Report Number
    1819470-2002-00014
    Event Type
    Malfunction
    Date Received
    May 2, 2002
    Report Date
    April 2, 2002
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, WAS REPORTED BY A NURSE VIA A SALES REP, WHO CONTACTED THE CO TO REPORT A PRODUCT COMPLAINT, WHICH CONCERNS A PT ADD'L INFO WAS LATER RECEIVED FROM THE PT VIA A STAFF MEMBER OF THE JAPAN DEVICE UNIT (JDU). THE PT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PT WAS TAKING AN UNSPECIFIED TYPE AND BRAND OF HUMAN INSULIN. IN 2002, THE PT WAS SWITCHED FROM HUMAPEN ERGO WITH AN OPAQUE CARTRIDGE HOLDER (OCH) TO A NEW HUMAPEN ERGO WITH CLEAR CARTIDGE. HOLDER (CCH). IT WAS REPORTED THAT WHEN THE PATIENT TRIED TO PUT THE CLEAR CARTRIDGE HOLDER (CCH) INTO THE HUMAPEN ERGO, THERE WAS MORE RESISTANCE THAN USUAL. THE PT THOUGHT THIS RESISTANCE WAS COMING FROM THE ENGAGEMENT TABS, WHICH SEEMED UNNECESSARY PARTS THE PT THEN CUT OFF BOTH ENGAGEMENT TABS WITH NIPPERS (C1D132389, LOTA1358). THE PT WAS UNABLE TO PERFORM "PRIMING" BECAUSE HAD CUT OFF THE (ENGAGEMENT) TABS AND CALLED THE HOSPITAL THINKING THERE WAS SOMETHING WRONG WITH THE PEN DEVICE. AT THAT TIME, THE PT THEN INJECTED THE DRUG VIA THE PREVIOUS HUMAPEN ERGO OPAQUE CARTRIDGE HOLDER (OCH). NO ADVERSE EVENTS WERE EXPERIENCED. IT IS UNKNOWN IF THE HUMAPEN ERGO WAS CONTINUED. NO ADD'L INFO IS EXPECTED. THE DEVICE WAS OPERATED BY THE PT. IT IS UNKNOWN IF THE PT WAS A TRAINED USER, OR WHAT DURATION OF TIME THE PT HAD USED HUMAPEN ERGO PENS. THE HUMAPEN ERGO WITH CLEAR CARTRIDGE HOLDER WAS RETURNED TO THE CO FOR ANALYSIS. THE REPORTING NURSE DID NOT PROVIDE ANY RELATEDNESS INFO REGARDING THE DEVICE. INITIAL ANALYSIS BY THE AFFILIATE QUALITY CONTROL DEPARTMENT FOUND: TWO BROKEN ENGAGEMENT TABS. THE COMPLAINT DEVICE WAS SENT TO PHARMACEUTICAL DELIVERY SYSTEMS FOR FURTHER DETAILED ANALYSIS. PHARMACEUTICAL DELIVERY SYSTEMS PROVIDED DETAILED ANALYSIS RESULTS ON MAY-2002: A DETAILED INVESTIGATION WAS COMPLETED BY EXAMINATION OF THE CLEAR CARTRIDGE HOLDER PHOTOGRAPHS PROVIDED BY THE JAPANESE AFFILIATE. THE TOP OF TAB "A" IS 'NECKED' IN - CONSISTENT WITH CUTTING, LIKELY A SMALL SCISSORS. THE "B" TAB POSSIBLE EXHIBITS SIMILAR 'NECKED' - IN APPEARANCE. THE ROOT CAUSE FOR THE CLEAR CARTRIDGE HOLDER ENGAGEMENT TAB DAMAGE IS UNDETERMINED, AS THE PART IS UNAVAILABLE FOR PHYSICAL EXAMINATION. HOWEVER, BASED ON THE LIMITED PHOTOGRAPHIC EVIDENCE, THE SUSPECT ROOT CAUSE IS CUTTING WITH AN UNKNOWN TOOL. THIS DAMAGE IS BELIEVED TO HAVE OCCURRED WHILE THE DEVICE WAS IN THE FIELD. UPDATE: APR-2002 INTERNAL EDIT: CHANGED TO ERGO TYPE (M58335) WITH LOT NUMBER A1358 PER GPCMS AND INITIAL REPORT. UPDATE MAY-2002 PHARMACEUTICAL DELIVERY SYSTEMS ENTERED RESULTS/CONCLUSIONS AND CORRECTIVE ACTION ON THE SUSPECT DEVICE PAGE, UPDATED THE NARRATIVE AND THE EVAL CONCLUSION. UPDATED: MAY-2002: ADD'L INFO REC'D ON APR-2002 FROM THE PT VIA CO REP. UPDATED SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO 3 ML PEN INJECTOR KZE ELI LILLY AND CO. MS8335 A1358

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR