BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1982621 · Received January 13, 2011

    Report

    Report Number
    2531779-2011-00275
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    December 15, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. THE EVAL OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVAL IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT CONTACTED ANIMAS ALLEGING THE PUMP GOT VERY HOT THE NIGHT BEFORE, AFTER RECEIVING A LOW BATTERY ALARM AT 11:46 PM. THE PT REPORTEDLY REMOVED THE BATTERY WHICH SHE CLAIMED WAS ALSO HOT. THE PT DENIED THAT THERE WERE ANY SIGNS OF CORROSION OR MOISTURE. THE PT ALSO DENIED EXPERIENCING ANY INJURIES OR BURNS DUE TO THE ALLEGED ISSUE. THE ANIMAS REP INSTRUCTED THE PT TO COME OFF OF THE PUMP AND TO USE A BACKUP PLAN. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT THE PUMP AND PUMP BATTERY FELT HOT. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PT DENIED THAT SHE SUFFERED ANY HARM OR INJURY BECAUSE OF THE ALLEGED 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1