BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR CH

    MDR report key: 1172044 · Received September 17, 2008

    Report

    Report Number
    1819470-2008-00048
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    August 21, 2008
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    FMF
    PMA / PMN Number
    K982842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SUGGESTIVE OF REPORTABLE MALFUNCTION/NEAR INCIDENT. WILL INVESTIGATE FURTHER. NOTE: THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.

    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 MALE PATIENT OF UNKNOWN AGE AND ORIGIN. RELEVANT MEDICAL HISTORY WAS NOT REPORTED. CONCOMITANT MEDICATIONS INCLUDED INSULIN GLARGINE. THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNKNOWN INDICATION BEGINNING ON AN UNKNOWN DATE. IN 2008, IT WAS REPORTED THAT THE CLASPS WERE BROKEN OFF HIS HUMAPEN ERGO TEAL (CLEAR CARTRIDGE) DEVICE (LOT NUMBER UNKNOWN, THE PATIENT DISCARDED THE PEN). THIS HUMAPEN ERGO TEAL DEVICE WAS ASSOCIATED WITH ANOTHER DEVICE. THE PATIENT WAS THE OPERATOR OF THE DEVICE. IT WAS UNKNOWN IF THE PATIENT WAS A TRAINED USER. THE PATIENT HAD USED THIS DEVICE MODEL SINCE 2000. THE PATIENT USED THE INSULIN GLARGINE WITH THIS DEVICE. IT WAS UNKNOWN IF THE USE OF THE HUMAPEN ERGO TEAL DEVICE WAS CONTINUED. FURTHER INFORMATION WILL BE ADDED IF RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR CH PEN INJECTOR FOR TREATMENT PURPOSES FMF ELI LILLY AND COMPANY MS8929 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LANTUS (INSULIN GLARGINE)