BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4122476 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27665
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/03/2014 WITH THE FOLLOWING FINDINGS: THERE WAS NO DAMAGE FOUND IN OR AROUND THE CARTRIDGE COMPARTMENT; THE COMPLAINT COULD NOT BE CONFIRMED ON INVESTIGATION. UNRELATED TO THE ORIGINAL COMPLAINT, INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED IN MULTIPLE AREAS. ADDITIONALLY, THE DISPLAY SCREEN WAS DIM AND FADED AND THE DISPLAY SCREEN TEXT WAS 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 THAT THE CARTRIDGE COMPARTMENT WAS CRACKED. 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
    601297 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1