BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, BURG/CLEAR

    MDR report key: 5322429 · Received September 17, 2004

    Report

    Report Number
    1819470-2004-00022
    Event Type
    Malfunction
    Date Received
    September 17, 2004
    Report Date
    August 18, 2004
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    NSC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S PRELIMINARY COMMENTS: THE CONTENTS OF THE COMPLAINT NARRATIVE SUGGEST THAT THIS DEVICE MAY HAVE HAD BOTH ENGAGEMENT TABS BROKE. HOWEVER, THIS CANNOT BE CONFIRMED WITHOUT THE DEVICE. IN THE EVENT THAT THE DEVICE IS RETURNED, IT WILL BE EVALUATED TO DETERMINE IF A REPORTABLE MALFUNCTION/HEAR INCIDENT HAS OCCURRED. ADDITIONAL MANUFACTURER NARRATIVE: NO FURTHER FOLLOW IS PLANNED. RESULTS/CONCLUSIONS: THIS DEVICE IS USED FOR TREATMENT PURPOSES. THE ACTUAL DEVICE WAS NOT RETURNED BECAUSE THE PT PLANS TO CONTINUE USING IT. HOWEVER, THE CONTENTS OF THE COMPLAINT NARRATIVE SUGGESTED THAT THE DEVICE MAY HAVE HAD BOTH ENGAGEMENT TABS BROKEN. THE REPORTED MALFUNCTION IS: CLEAR CARTRIDGE HOLDER, BOTH ENGAGEMENT TABS BROKEN. THIS MALFUNCTION HAS BEEN SHOWN TO CAUSE AN UNDERDOSE. CORRECTIVE ACTION: EVIDENCE OF IMPROPER USE/STORAGE: THE USER PROVIDED INFO TO INDICATE IMPROPER USE, I.E., CONTINUING TO USE THE DEVICE THAT MAY HAVE BOTH ENGAGEMENT TABS BROKEN. THIS MALFUNCTION HAS BEEN SHOWN TO CAUSE AN UNDERDOSE.

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A CONSUMER, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT, CONCERNS A (B)(6) MALE PT OF UNK ORIGIN. THE PT'S MEDICAL HISTORY AND CONCOMITANT MEDICATION WERE NOT PROVIDED. THE PT WS TAKING AN UNSPECIFIED MEDICATION VIA A HUMAPEN ERGO BURGUNDY/CLEAR PEN BODY (LOT UNK) FOR AN UNK INDICATION. IT WAS UNK IF THE PERSON OPERATING THE DEVICE WAS THE PT OR IF THE OPERATOR OF THE DEVICE WAS TRAINED. THE PT REPORTED THAT BOTH SMALL TABS BROKE OFF THE CARTRIDGE HOLDER. THIS HUMAPEN ERGO COMPLAINT IS ASSOCIATED WITH (B)(6). THE COMPANY REQUESTED THE RETURN OF THE DEVICE ON TWO OCCASIONS, HOWEVER, TH REPORTER REFUSED TO RETURN THE DEVICE TO THE COMPANY. UPDATE 09/16/2004: RECEIVED PRODUCT COMPLAINT FOLLOW UP 09/16/2004, ADDED RESULTS/CONCLUSIONS, UPDATED SUSPECT DEVICE PAGES, NARRATIVE AND CIOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, BURG/CLEAR PEN INJECTOR NSC ELI LILLY AND CO. MS8930 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR