BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 2903702 · Received January 9, 2013

    Report

    Report Number
    2531779-2013-00406
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 12, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: REVIEW OF THE ALARM HISTORY REVEALED CALL SERVICE ALARMS RECORDED. THE BLACK BOX DATA FOR THESE RECORDS IS NOT AVAILABLE AS THE BLACK BOX INFORMATION FOR THAT DATE HAD BEEN OVERWRITTEN DUE TO CONTINUED PATIENT USE. REVIEW OF THE BOLUS HISTORY REVEALED NO RECORD OF PARTIAL DELIVERY OF THE BOLUSES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH SEVERAL BOLUSES PERFORMED WITH NO DELIVERY ISSUES AND NO CALL SERVICE ALARMS. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE COMPLAINT WAS CONFIRMED IN THE PUMP HISTORY BUT COULD NOT BE DUPLICATED DURING INVESTIGATION.

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE DISTRIBUTOR CONTACTED ANIMAS AND REPORTED SEVERAL CALL SERVICE ALARMS. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10720 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS VIBE INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1