BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3955505 · Received July 24, 2014

    Report

    Report Number
    2531779-2014-21292
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 09/02/2014 WITH THE FOLLOWING FINDINGS: THE INITIAL COMPLAINT COULD NOT BE INVESTIGATED DUE TO A DISPLAY FAILURE, THUS NO CONCLUSIONS CAN BE MADE IN THIS REGARD. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AT THE THREADS AND CASE SEAL. THE PUMP POWERED ON, AS CONFIRMED BY THE PRESENCE OF THE AUDITORY AND VIBRATORY CUES, BUT THE DISPLAY SCREEN WAS BLANK. THE PUMP CASE WAS REMOVED, AND EVIDENCE OF CORROSION WAS OBSERVED ON THE DISPLAY AND ALONG THE BATTERY CYLINDER. THE SUSPECT DISPLAY SCREEN WAS REPLACED WITH A TEST DISPLAY SCREEN; THE PUMP DISPLAY FUNCTIONED PROPERLY WITH THE TEST DISPLAY SCREEN INSTALLED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) 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
    435048 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR