BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3831381 · Received May 24, 2014

    Report

    Report Number
    2531779-2014-14747
    Event Type
    Malfunction
    Date Received
    May 24, 2014
    Report Date
    May 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE INVESTIGATED DUE TO AN UNRELATED ISSUE. REVIEW OF THE PUMP¿S BLACK BOX REVEALED RELATED ALARMS. THE PUMP COULD NOT COMPLETE A 24-HOUR EXERCISE TEST DUE TO A RECURRING UNRELATED ALARM. UNRELATED TO THE COMPLAINT, THE BOLUS BUTTON WAS FOUND TO BE MISSING. CORROSION WAS OBSERVED ON THE BOLUS BUTTON CONTACT. A BATTERY COMPARTMENT CRACK WAS DISCOVERED; THERE WAS NO EVIDENCE OF BATTERY COMPARTMENT MOISTURE INGRESS. THE RETURNED BATTERY CAP THREADS WERE DAMAGED AND THE BATTERY CAP WAS UNABLE TO BE PROPERLY SECURED. THE KEYPAD WAS FOUND TO BE TORN. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS WERE APPROPRIATELY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL KEY CONTACTS. INVESTIGATION REVEALED THE DISPLAY SCREEN WAS DIM AND DISCOLORED. LEAK TESTING REVEALED A BOLUS BUTTON LEAK. CORROSION WAS OBSERVED ON THE MOTOR DRIVE FLEX CABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 078) ISSUE. 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
    309483 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR