BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 1820015 · Received August 30, 2010

    Report

    Report Number
    1819470-2010-00061
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Report Date
    August 18, 2010
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K982842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (B)(4). THIS DEVICE CASE, WHICH DID NOT INVOLVE ANY ADVERSE EVENTS, REPORTED BY A CONSUMER VIA A PHARMACIST WHO CONTACTED THE AFFILIATE WITH A PRODUCT COMPLAINT, CONCERNS A FEMALE OF (B)(6). THE PATIENT RECEIVED SUBCUTANEOUS INSULIN LISPRO PROTAMIN SUSPENSION 75%/ INSULIN LISPRO 25% VIA A HUMAPEN ERGO TEAL/CLEAR PEN BODY (LOT#: NOT PROVIDED) WITH CLEAR CARTRIDGE HOLDER ATTACHED, DOSAGE, INDICATION FOR USE OR START DATE WERE NOT PROVIDED. SHE USED THIS HUMAPEN ERGO OVER 10 YEARS THOUGH START DATE WAS NOT PROVIDED. ON UNKNOWN DATE, OVER TEN YEARS AFTER USING THIS HUMAPEN ERGO, SHE FOUND THAT INNER PARTS OF THE CARTRIDGE HOLDER TO FIX IT WERE BROKEN. AFTER THAT SHE ALSO FOUND THE CRACKS IN THE CLEAR CARTRIDGE HOLDER. AS OF (B)(6) 2010, SHE DID NOT REPORT ANY HEALTH PROBLEMS. IT WAS NOT PROVIDED IF SHE CONTINUED INSULIN TREATMENT WITH HUMAPEN ERGO OR NOT. THIS HUMAPEN ERGO (LOT#: NOT PROVIDED) WITH CLEAR CARTRIDGE HOLDER IS ASSOCIATED WITH (B)(4). THE OPERATOR, TRAINING STATUS, STORAGE CONDITION WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS8220 0401A05

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HUMALOG MIX 25