BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2770527 · Received October 3, 2012

    Report

    Report Number
    2531779-2012-11714
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 23, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 11/19/2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS, ALLEGING ALL THE KEYPAD BUTTONS HAD A DELAYED RESPONSE. THE PATIENT DENIED DAMAGE TO THE KEYPAD. THE PATIENT REPORTEDLY WORE THE PUMP UNDER A GARMENT, AGAINST THE BODY AND DID NOT CLEAN IT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    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 67 YR