BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2933807 · Received January 29, 2013

    Report

    Report Number
    2531779-2013-01326
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/06/2015 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR DAMAGE WAS OBSERVED. DURING TESTING, ALL OF THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY UNRESPONSIVE. THE KEYPAD COVER WAS REMOVED AND THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL OF THE KEY CONTACTS. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED A DIM DISPLAY WITH DISCOLORED TEXT AND MULTIPLE CRACKS IN THE BATTERY COMPARTMENT. ALSO UNRELATED TO THE COMPLAINT, THE AUDIO BOLUS BUTTON WAS FOUND TO BE UNRESPONSIVE. THERE WAS NO DAMAGE OBSERVED IN THE AUDIO BOLUS BUTTON.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    ON (B)(4) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER STATED THAT THE UP ARROW, DOWN ARROW AND OK KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE AND REQUIRED MULTIPLE BUTTON PRESSES TO ELICIT A RESPONSE. IT WAS NOTED THAT THE OK BUTTON WAS HYPER-RESPONSIVE. 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
    39557 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR