BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2173971 · Received July 24, 2011

    Report

    Report Number
    2531779-2011-05182
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: DURING EVALUATION THE PUMP WAS ABLE TO POWER ON PROPERLY AND WAS EXERCISED FOR 24 HOURS WITH NO POWER LOSS. A REVIEW OF THE PUMP HISTORY INDICATED THAT A POWER LOSS HAD OCCURRED HOWEVER IT COULD NOT BE DUPLICATED. THE PUMP WAS OPENED FOR INVESTIGATION. NO DAMAGE OR DEFECTS WERE OBSERVED TO THE BATTERY TERMINALS OR OTHER COMPONENTS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    THE PATIENT CONTACTED ANIMAS ALLEGING THE PUMP HAS INTERMITTENTLY BEEN POWERING OFF ON ITS OWN. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN SEVERAL DAYS PRIOR TO CONTACTING ANIMAS. THE PATIENT CLAIMED SHE WOULD HAVE TO "SHAKE" PUMP TO "WAKE UP AND OBTAIN VERIFICATION SCREEN". THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. AT THE TIME OF TROUBLESHOOTING, THE PATIENT DENIED ANY VISIBLE DAMAGE TO THE BATTERY CAP OR CORROSION IN THE BATTERY COMPARTMENT. THE ALLEGED POWER ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR