BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 2910479 · Received January 11, 2013

    Report

    Report Number
    2531779-2013-00532
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Report Date
    December 25, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    (B)(4). DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: REVIEW OF THE ALARM HISTORY REVEALED ONE CALL SERVICE ALARM OCCURRING ON (B)(4) 2012 AT 3:03. REVIEW OF THE BLACK BOX REVEALED A PROGRAMMED BOLUS OF 1.5 UNITS WITH THE CALL SERVICE ALARM OCCURRING AFTER DELIVERY OF APPROXIMATELY 0.472 UNITS OF THAT BOLUS. REVIEW OF THE BOLUS HISTORY REVEALED NO RECORD OF A PARTIAL BOLUS RECORDED ON THE TIME/DATE OF THE REPORTED EVENT. ON TESTING, THE PUMP POWERED ON WITH APPROPRIATE AUDITORY AND VIBRATORY FUNCTION. AN EZ-PRIME OPERATION WAS EXECUTED WITHOUT INCIDENT. THE PUMP WAS EXERCISED FOR 24 HOURS WITH A VARIETY OF BOLUSES PROGRAMMED AND DELIVERED WITHOUT A CALL SERVICE ALARM OCCURRING. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT THAT WAS VERIFIED IN THE BLACK BOX RECORDS.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012, ALLEGING THE PUMP EMITTED A CALL SERVICE ALARM DURING A BOLUS DELIVERY. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE CALL SERVICE ALARM EMITTED INDICATED THAT THE BOLUS MAY NOT HAVE BEEN RECORDED IN THE PUMP HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16473 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS VIBE INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR