BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3982865 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22495
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 26, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 EVALUATED BY PRODUCT ANALYSIS ON 10/07/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT MULTIPLE CONSECUTIVE POWER REBOOTS HAD OCCURRED ON (B)(6) 2014. THE BATTERY VOLTAGE PRIOR TO THE POWER REBOOTS WAS ABOVE THE BATTERY ALARM/WARNING THRESHOLD. VISUAL INSPECTION REVEALED THAT THERE WAS A HAIRLINE CRACK THROUGH THE THREADS. ANOTHER CRACK WAS OBSERVED AT THE BUMPER PAD EXTENDING TO THE CASE SEAL. THE RETURNED BATTERY CAP WAS UNDAMAGED AND WAS ABLE TO MAINTAIN AN ELECTRICAL CONNECTION WITH THE PUMP. MOISTURE CORROSION WAS OBSERVED IN THE BATTERY COMPARTMENT AND ON THE BATTERY CAP. A LEAK TEST WAS PERFORMED AND A BATTERY COMPARTMENT LEAK WAS FOUND. NO POWER INTERRUPTIONS, ERRORS, ALARMS, OR WARNINGS OCCURRED DURING INVESTIGATION. THE PUMP CASE WAS REMOVED AND MOISTURE CORROSION WAS OBSERVED ON THE PRINTED CIRCUIT BOARD. THERE WERE NO INTERMITTENT CONDITIONS FOUND TO THE PRINTED CIRCUIT BOARD. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE COMPLAINT THAT THE PUMP HAD NO POWER WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THAT THE PUMP HAD NO POWER. IT WAS NOTED THAT THERE WAS MOISTURE/CORROSION IN THE BATTERY COMPARTMENT. 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
    459298 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR