BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2172699 · Received July 22, 2011

    Report

    Report Number
    2531779-2011-05121
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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: THE KEYPAD WAS FOUND TO BE WORN BUT INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE 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

    THE PATIENT'S MOTHER STATED THAT THERE IS AN INTERMITTENT DELAY IN ACTIVATING DESIRED PUMP FUNCTIONS AFTER PRESSING KEYPAD BUTTONS. SHE REPORTED NO SIGNS OF DAMAGE TO THE KEYPAD BUT NOTICES THAT THE LETTERING ON THE OK BUTTON IS WORN OFF ON THE KEYPAD. THE REPORTER STATES THE PUMP DOES NOT GET CLEANED. THERE WAS NO EVIDENCE OF MISUSE OF THE PRODUCT. THERE WAS NO REPORTED 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 6 YR