BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2851404 · Received November 29, 2012

    Report

    Report Number
    2531779-2012-14073
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 17, 2012
    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

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: PUMP WAS RETURNED WITH VISIBLE MOISTURE IN THE DISPLAY LENS. PUMP DOES NOT POWER ON, NO VIBRATORY OR AUDIBLE SOUNDS. THE ATTEMPT TO DOWNLOAD THE PUMP HISTORY AND BLACK BOX WAS UNSUCCESSFUL. A CASE SEAL LEAK WAS FOUND DURING A LEAK TEST. DAMAGE TO THE PUMP CASE WAS OBSERVED ON THE TOP RIGHT CORNER OF THE PUMP BETWEEN THE DISPLAY LENS AND THE CASE SEAL. REMOVED PUMP COVER; INTERNAL MOISTURE WAS FOUND IN PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A SCRATCHED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THEY WENT SWIMMING WITH THE PUMP AND THE PUMP NOW HAS WATER IN IT AND BEHIND THE DISPLAY. THE PATIENT REPORTED THAT THE PUMP WILL NOT HOLD POWER. THE PATIENT STATED THAT THE PUMP BEEPED AND THEN SHUT OFF. THE PATIENT CONFIRMED THAT THERE IS NO DAMAGE TO THE PUMP, BATTERY COMPARTMENT OR BATTERY CAP. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE POWER ISSUE.

    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 18 YR