BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2220656 · Received August 23, 2011

    Report

    Report Number
    2531779-2011-06129
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: INVESTIGATION REVEALED THAT ALL KEYPAD BUTTONS RESPONDED AS EXPECTED. THERE WAS NO PHYSICAL DAMAGE TO THE KEYPAD. THERE WAS NO KEYPAD BUTTON DEFECT FOUND ON INVESTIGATION. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE VIBRATION MOTOR PINS WERE NOT MAKING AN ELECTRICAL CONNECTION WITH THE PCB. THE ALLEGED MALFUNCTION IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE AUDIBLE ALARM MECHANISM STILL FUNCTIONS AND WILL STILL ALERT THE USER SHOULD THE PUMP EMIT AN ALARM.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED KEYPAD ISSUE. REPORTEDLY, ALL KEYPAD BUTTONS ARE NOT RESPONDING TO USER INPUT. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE PUMP IS BEING RETURNED FOR INVESTIGATION. THE PATIENT WILL GO ON THE BACKUP PLAN AS NEEDED. THERE WAS NO REPORT OF PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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 15 YR