BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2142284 · Received June 28, 2011

    Report

    Report Number
    2531779-2011-04523
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. THE DOWN-ARROW AND OK BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS DURING TESTING. THE UP-ARROW AND CONTRAST BUTTONS REQUIRED EXCESSIVE FORCE TO ACTIVATE A RESPONSE. THE UP-ARROW AND DOWN-ARROW KEY CONTACTS WERE FOUND TO BE MISALIGNED. IT WAS FOUND THAT ALL KEY CONTACTS DO NOT SPRING BACK WHEN PRESSED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. THE DHR REVIEW CONFIRMED THE PUMP WAS WITHIN SPECIFICATION WITH NO DISCREPANCIES IDENTIFIED, SOFTWARE VERSION D1E, MFG 2009-04.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE KEYPAD HAS A DELAYED RESPONSE.

    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 66 YR