BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2143218 · Received June 28, 2011

    Report

    Report Number
    2531779-2011-04539
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE BATTERY WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. THERE WAS NO ACTIVITY RELATED TO THE COMPLAINT NOTED IN THE PUMP HISTORY. THERE WAS NO DAMAGE FOUND TO THE BATTERY COMPARTMENT. EVALUATION FOUND THAT THE PUMP POWERS UP PROPERLY AND THE POWER CIRCUIT DOES NOT DRAW EXCESSIVE CURRENT. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO OVERHEATING OBSERVED. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED. INVESTIGATION REVEALED A KEYPAD LEAK AND MOISTURE DAMAGE ON THE PRINTER CIRCUIT BOARD.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTIONED DUE TO THE ALLEGED ANIMAS PUMP TEMPERATURE ISSUE. THE ANIMAS PUMP FELT HOT WHEN SHE REPLACED THE BATTERY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE TEMPERATURE ISSUE. THERE WAS NO CORROSION IN THE BATTERY COMPARTMENT OR ON THE BATTERY. NO PRODUCT MISUSE WAS IDENTIFIED. THE KEYPAD WAS NOTED TO BE PEELING.

    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 32 YR