BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2151768 · Received July 6, 2011

    Report

    Report Number
    2531779-2011-04711
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Report Date
    June 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: THE BATTERY CAP RETURNED WITH THE PUMP WAS FOUND TO HAVE STRIPPED THREADS, AND WOULD NOT PROPERLY SECURE TO THE PUMP. A TEST CAP WAS USED DURING EVALUATION. THE PUMP POWERS ON APPROPRIATELY WITH THE TEST CAP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING. A REVIEW OF THE PUMP HISTORY INDICATED THAT REBOOTING HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. THE COMPLAINT REGARDING POWER LOSS COULD NOT BE 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 BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP LOST POWER FIVE TIMES THE MORNING OF THE CALL AND ONE TIME THE AFTERNOON OF THE CALL. THE PATIENT NOTICED ISSUE IMMEDIATELY. HE HAD NO BLOOD GLUCOSE EXCURSIONS. HE REPORTED THAT THE BATTERY WAS REPLACED TWO WEEKS AGO. THE ALARM HISTORY WAS REVIEWED AND NO ASSOCIATED ALARMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR