BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2033436 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01865
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 20, 2011
    Report Date
    February 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVAL IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/RPTR INDICATED THAT THE ANIMAS PUMP HAS A POWER ISSUE. AFTER THE RPTR CHANGES THE BATTERY ON THE DAY OF THE CALL, THE ANIMAS INSULIN PUMP KEEPS PROMPTING A VERIFICATION SCREEN. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE BATTERY CAP IS TIGHT. THE THREADING ON THE BATTERY CAP DID NOT APPEAR WORN. THERE WAS NO VISIBLE DAMAGE ON THE SUBJECT PRODUCT. THERE WAS NO REPORT OF A SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1