BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2213134 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05934
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 19, 2011
    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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE WORN BUT INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS ARE UNRESPONSIVE. THERE WAS MOISTURE OBSERVED IN THE DISPLAY SCREEN, AND EVIDENCE OF RESIDUAL MOISTURE ON THE PCB. A LEAK TEST WAS PERFORMED AND A BATTERY COMPARTMENT LEAK WAS OBSERVED. EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP.

    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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT WHILE AT A WATER PARK, THE KEYPAD BUTTONS BECAME UNRESPONSIVE. THE PATIENT REPORTED THAT SHE WAS TRYING TO CHANGE THE INSET WHEN SHE FIRST NOTICED THE ISSUE. DURING THE CALL, THE PATIENT COULD NOT GET OUT OF THE VERIFY SCREEN. THE PATIENT REPORTEDLY WORE THE PUMP IN A POCKET AND DID CLEANED THE PUMP WITH ALCOHOL SWABS. CUSTOMER SUPPORT ADVISED THE PATIENT NOT TO CLEAN THE PUMP WITH SOLVENTS.

    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 22 YR