BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3913744 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-18981
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 18, 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 DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/31/2014 WITH THE FOLLOWING FINDINGS: THERE WAS NO EVIDENCE OF SHORT BATTERY LIFE OBSERVED. THERE WERE TWO LOW CARTRIDGE WARNINGS OBSERVED ON 06/15/2014 AS A RESULT OF NORMAL BATTERY WEAR. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED AT THE THREADS AND AT THE SEALING. NO BATTERY CAP WAS RETURNED WITH THE PUMP. A TEST CAP WAS ABLE TO FIT SECURELY ONTO THE PUMP AND MAINTAINED AN ELECTRICAL CONNECTION. NO SHORT BATTERY LIFE WAS DUPLICATED DURING THE INVESTIGATION AND ALL CURRENT READINGS WERE WITHIN SPECIFICATION. THERE WAS NO INTERMITTENT CONDITION FOUND TO THE POWER CIRCUIT AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. 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. 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. THE REPORTER STATED THAT THE ALARM HISTORY INDICATED THAT THE BATTERY LIFE WAS LESS THAN EXPECTED. 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
    389821 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR