BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2933804 · Received January 29, 2013

    Report

    Report Number
    2531779-2013-01320
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) 2013 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: REBOOTING WAS OBSERVED IN THE PUMP BLACK BOX. THERE WAS NO DAMAGE OBSERVED TO THE BATTERY COMPARTMENT; THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. A TEST CAP WAS INSERTED FOR TESTING PURPOSES. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES OCCURRING. THE PUMP WAS OPENED AND THERE WAS NO DAMAGE FOUND TO THE POWER CIRCUIT.

    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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER ISSUE. THE PUMP REPORTEDLY LOST POWER AND THE REPORTER ATTEMPTED TO POWER THE PUMP ON WITH ADDITIONAL BATTERY CHANGES WITH NO SUCCESS. 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
    39556 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR