BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3944383 · Received July 18, 2014

    Report

    Report Number
    2531779-2014-20655
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 11, 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 5/11/2017. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 4/19/2017 WITH THE FOLLOWING FINDINGS:THERE WAS EVIDENCE OF ¿NO CARTRIDGE DETECTED¿ WARNINGS OBSERVED IN THE PUMP¿S BLACK BOX HISTORY. A MOTOR REWIND ERROR OCCURRED DURING THE CARTRIDGE REWIND STEP DUE TO AN UNIDENTIFIED PRINTED CIRCUIT BOARD (PCB) FAILURE WITHIN THE MOTOR CIRCUIT. THE PUMP WAS OPENED AND THE FORCE SENSOR PIN WAS FOUND TO BE CRACKED AND A CRACKED SOLDER WAS FOUND ON THE PIEZO. THE AUDIO TONE ALARM WAS INOPERABLE. UNRELATED TO THE INITIAL COMPLAINT, IT WAS OBSERVED THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP AND A TEST CAP WAS USED TO COMPLETE THE 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 PRIME (LOAD STEP MALFUNCTION) ISSUE. IT WAS REPORTED THAT THE PUMP WAS PRIMING THE TUBING DURING THE LOAD STEP. 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
    421413 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR