BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4121160 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27583
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/08/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX REVEALED MULTIPLE CALL SERVICE (CS) 177 WARNINGS DUE TO A NONE-FULLY CHARGED BATTERY. A REVIEW OF THE PUMP HISTORY INDICATED NO EVIDENCE OF ¿SHORT BATTERY¿ LIFE OBSERVED. THE RETURNED BATTERY CAP AND CARTRIDGE CAP WERE USED TO COMPLETE THE INVESTIGATION. DURING EVALUATION, THE PUMP ALARMED A CALL SERVICE ALARM UPON THE FIRST ¿REWIND¿ ATTEMPT AND THE REMAINING STEPS FOR THE ¿SHORT BATTERY LIFE¿ ISSUE WAS UNABLE TO BE INVESTIGATED. THE PUMP¿S COVER WAS REMOVED; THE BATTERY COMPARTMENT WAS ALSO FOUND TO BE CRACKED FROM THE CASE SEAL UP TO THREADS AND THERE WAS MOISTURE AND CORROSION FOUND TO THE PCB AND ON THE MOTOR FLEX/CONNECTOR. 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.

    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. 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ DAMAGE) ISSUE; LESS THAN EXPECTED BATTERY LIFE WITH A CRACKED BATTERY COMPARTMENT AND CALL SERVICE ALARM (078). 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
    601547 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR