BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3842150 · Received May 31, 2014

    Report

    Report Number
    2531779-2014-15305
    Event Type
    Malfunction
    Date Received
    May 31, 2014
    Report Date
    May 26, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA REVEALED A PUMP REBOOT. DURING A VISUAL INSPECTION OF THE PUMP, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. THE RETURNED BATTERY CAP THREADS WERE ALSO FOUND TO BE STRIPPED. DURING TESTING, THE BATTERY CAP DID NOT SECURE PROPERLY TO THE PUMP AND A POWER LOSS WAS DUPLICATED. A TEST BATTERY CAP SECURED PROPERLY TO THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS. THE PUMP CASE WAS REMOVED, AND NO EVIDENCE OF MOISTURE INGRESS OR DAMAGE TO THE POWER CIRCUIT WAS FOUND.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. IT WAS REPORTED THAT THE PUMP INTERMITTENTLY LOST POWER. ALLEGEDLY, THE BATTERY COMPARTMENT WAS CRACKED, AND THE YELLOW O-RING OF THE BATTERY CAP WAS VISIBLE WHILE THE CAP WAS ATTACHED TO THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320306 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR