BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2931220 · Received January 28, 2013

    Report

    Report Number
    2531779-2013-01220
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 03/21/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: BLACK BOX REVIEW SHOWS NUMEROUS UNUSUAL POWER ON RESET. THE BATTERY CAP AND BATTERY COMPARTMENT THREADS WERE INTACT AND NO CRACKS OBSERVED IN THE BATTERY COMPARTMENT. THE BATTERY CAP HEIGHT INCH WAS ABOVE SPECIFICATIONS AND THE WIDTH INCH WITHIN SPECIFICATIONS. THE BATTERY CAP IS ABLE TO MAINTAIN AN ELECTRICAL CONNECTION, THE PUMP POWERS ON NORMAL WITH NO ALARMS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DIM DISPLAY SCREEN.

    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 REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP REBOOTED TWO TIMES IN 15 MINUTES. HE STATED THAT EACH TIME THEY WILL HEAR THE PUMP BEEP AND VERIFY SCREEN CAME UP. THE REWIND, LOAD AND PRIMES STEPS WERE COMPLETED. THE REPORTER CONFIRMED THAT THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT OR BATTERY CAP AND THE BATTERY CAP SECURES PROPERLY TO PUMP, NO YELLOW SHOWING. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE INTERMITTENT POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36831 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR