BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2933310 · Received January 29, 2013

    Report

    Report Number
    2531779-2013-01295
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 03/01/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO PEELING OR DAMAGE WAS OBSERVED. DURING TESTING, ALL THE KEYPAD BUTTONS RESPONDED APPROPRIATELY. THE SYMBOLS ON THE KEYPAD BUTTONS WERE WORN, WHICH HAS NO EFFECT ON INSULIN DELIVERY. DURING INVESTIGATION, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: IT WAS INADVERTENTLY REPORTED THAT THE KEYPAD COVER WAS INTACT. EVALUATION REVEALED THAT THE KEYPAD COVER WAS PEELING. A DAMAGED KEYPAD WILL PERMIT CONTAMINATION TO PERMEATE THE BUTTONS WHICH WILL HAVE A NEGATIVE IMPACT ON BUTTON FUNCTION. THIS SITUATION IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT AS THE DAMAGED KEYPAD SHOULD BE CLEARLY VISIBLE AND WARNS THE PATIENT TO DISCONTINUE USING THE PUMP.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING THE UP ARROW AND OK KEYPAD BUTTONS WERE DIFFICULT TO PUSH AND REQUIRED MULTIPLE HARD PRESSES TO RESPOND. THE REPORTER NOTED THE KEYPAD RUBBER WAS PEELING. 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
    38995 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR