BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242429 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11682
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 18-JUL-2019 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP WAS POWERED WITH A CLEAR AND LEGIBLE DISPLAY. THE COMPLAINT OF A BLANK DISPLAY WAS NOT DUPLICATED. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED A DIM, DISCOLORED DISPLAY. THE PUMP WAS OPENED AND NO EVIDENCE OF MOISTURE WAS OBSERVED INSIDE THE PUMP. 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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THE REPORTER ALLEGED THAT AFTER THE BATTERY WAS CHANGED, THE DISPLAY SCREEN ON THE PUMP REMAINED BLANK AND THE REPORTER NOTED AUDIBLE TONES/VIBRATIONS. IT WAS REPORTED THAT THE PATIENT HAD BLOOD GLUCOSE (BG) OF 445MG/DL WITHOUT SYMPTOMS ON THE MORNING OF THE EVENT. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343013 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR