BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3863688 · Received June 10, 2014

    Report

    Report Number
    2531779-2014-16336
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    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

    FOLLOW-UP #1: DATE OF SUBMISSION 07/08/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/27/2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON WITH VIBRATORY AND AUDIBLE SOUNDS. THE DISPLAY SCREEN WAS BLANK AND WOULD NOT GO TO THE VERIFY SCREEN. THE PUMP WAS OPENED FOR INVESTIGATION AND THE DISPLAY SCREEN WAS OBSERVED TO BE CRACKED. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED AT THE CASE SEAL. THE RETURNED BATTERY CAP ATTACHED TO THE PUMP WITH NO ISSUES AND WAS USED TO COMPLETE TESTING.

    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
    338636 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR