BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3962825 · Received July 29, 2014

    Report

    Report Number
    2531779-2014-21647
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 09/09/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE DISPLAY LENS DID NOT HAVE A CLOUDY APPEARANCE, AND NO EVIDENCE OF MOISTURE INGRESS WAS OBSERVED BEHIND THE DISPLAY LENS; THE REPORTED EVENT WAS NOT DUPLICATED. THE PUMP CASE WAS CRACKED FROM THE DISPLAY LENS TO THE CASE SEAL, AND THE PUMP FAILED A LEAK TEST DUE TO THIS DAMAGE. THE PUMP CASE WAS REMOVED, AND CORROSION WAS FOUND ON AN INTERNAL SURFACE NEAR THE LOCATION OF THE CASE DAMAGE. THE RELATION OF THE MOISTURE-INGRESS EVENT TO THE REPORTED CLOUDY-DISPLAY EVENT COULD NOT BE DETERMINED. UNRELATED TO THE REPORTED EVENT, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED.

    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)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (CLOUDY W/ MOISTURE) ISSUE. THE REPORTER ALLEGED THAT MOISTURE WAS EVIDENT BEHIND THE DISPLAY LENS. REPORTEDLY, THE USER WAS ABLE TO READ THE DISPLAY SCREEN SAFELY. 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
    442193 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR