BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3973630 · Received August 1, 2014

    Report

    Report Number
    2531779-2014-22132
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/13/2014 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED FROM THREADS DOWN TO THE CASE SEAL. THERE WAS NO DAMAGE TO THE BATTERY CAP. THE BATTERY CAP SECURED TIGHTLY TO THE PUMP AND MAINTAINED AN ELECTRICAL CONNECTION. ALSO UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND FADED. ALSO UNRELATED TO THE COMPLAINT, THE PUMP EMITTED A CALL SERVICE (CS) 078 ALARM UPON THE FIRST REWIND ATTEMPT. THE PUMP COVER WAS REMOVED; MOISTURE CORROSION WAS FOUND ON THE PRINTED CIRCUIT BOARD TO THE MOTOR FLEX/CONNECTOR. H6 EVALUATION RESULTS CODES:

    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. (B)(6),

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE BATTERY COMPARTMENT REPORTEDLY 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
    449907 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1