BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 5100847 · Received September 24, 2015

    Report

    Report Number
    2531779-2015-34276
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    August 31, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: THE ISSUE WAS DUPLICATED ON INVESTIGATION; THE PUMP EMITTED A CALL SERVICE 69 ALARM DURING POWER UP. THE CALL SERVICE 69 FAILURE WAS WRITTEN TO THE BLACK BOX AS A CALL SERVICE 87 FAILURE. INVESTIGATION REVEALED THAT A LANGUAGE CORRUPTION OCCURRED AT A COMPONENT ON THE PRINTED CIRCUIT BOARD RESULTING IN A CALL SERVICE ALARM. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP WAS EMITTING CALL SERVICE 069 ALARMS. 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
    632090 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1