BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3842249 · Received May 31, 2014

    Report

    Report Number
    2531779-2014-15395
    Event Type
    Malfunction
    Date Received
    May 31, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: POWER ON RESETS OBSERVED IN THE BLACK BOX. BATTERY COMPARTMENT IS CRACKED BELOW THE BUMPER GRIP. NO DAMAGE FOUND TO RETURNED BATTERY CAP. THE RETURNED BATTERY CAP CONTACT MEASUREMENTS ARE IN SPECIFICATIONS. PUMP WAS EXERCISED FOR 24HR DURATION PERIOD USING THE RETURNED BATTERY CAP; NO POWER INTERRUPTIONS WERE DUPLICATED DURING TESTING WITH THE RETURNED BATTERY CAP. REMOVAL OF THE PUMP COVER; SHOWED NO EVIDENCE OF INTERNAL MOISTURE. NO DAMAGE TO THE POWER CIRCUIT WAS OBSERVED. THE COMPLAINT WAS CONFIRMED IN PUMP HISTORY BUT NOT DUPLICATED DURING TESTING. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    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 (INTERMITTENT POWER) ISSUE. 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
    320367 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR