BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3936928 · Received July 15, 2014

    Report

    Report Number
    2531779-2014-20197
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    July 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 08/20/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE KEYPAD COVER WAS INTACT. EVALUATION REVEALED THAT ALL OF THE KEYPAD BUTTONS WERE PROPERLY RESPONSIVE; THE REPORTED EVENT WAS NOT DUPLICATED. THE KEYPAD COVER WAS REMOVED, AND NO EVIDENCE OF CONTAMINATION WAS OBSERVED UNDER ANY OF THE KEY CONTACTS. UNRELATED TO THE REPORTED EVENT, THE DISPLAY SCREEN WAS DIM AND DISCOLORED. ALSO UNRELATED TO THE REPORTED EVENT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED FROM THE THREADS TO THE CASE SEAL. FURTHERMORE, THE BATTERY CAP WAS FOUND TO BE DAMAGED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THE UP, DOWN, AND OK KEYPAD BUTTONS WERE UNDER-RESPONSIVE. IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE (BG) WAS BETWEEN 250-499 MG/DL WITH NO SYMPTOMS. THE REPORTED BG EXCURSION DOES NOT MEET CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412059 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR