BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 2972270 · Received February 21, 2013

    Report

    Report Number
    2531779-2013-01999
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) -DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE BLACK BOX HISTORY CAPTURED CS 012 ON (B)(6) 2013 AT 12:51PM, AND ON (B)(6) 2013 AT 7:06PM, USER PROGRAMMED TWO BOLUSES OF 13.5 U EACH, THE CS 012 ALARMS EXERTED AFTER DELIVERY OF ~0.5 U. THE BOLUS HISTORY DID NOT CREATE A PARTIAL DELIVERY RECORD OF THE BOLUS. ONE FURTHER CS 012- CS 012 IS OBSERVED IN THE ALARM HISTORY ON (B)(6) 2013 AT 1:02PM. THE PUMP POWERS UP NORMALLY AND PRIMES CORRECTLY. DURING INVESTIGATION, PUMP WAS EXERCISED FOR 24 HR TO DELIVER A BASAL RATE OF 1 U/HR. MULTIPLE BOLUSES WERE PERFORMED DURING THE COURSE OF THE DURATION TEST INCLUDING 'EZ-BG,' 'EZ-CARB,' 'NORMAL' AND 'AUDIO BOLUSES,' PUMP DID NOT REPRODUCE ALARM DURING TESTING. THE PUMP WAS OPENED AND INSPECTED; NO MOISTURE INGRESS OR ANY INTERMITTENT CONDITION WAS FOUND TO THE PCB, OR TO THE FLEXES.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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) 2013, THE REPORTER CONTACTED ANIMAS AND REPORTED A CALL SERVICE 012 ALARM ISSUE. THE PATIENT REPORTEDLY RECEIVED THE CALL SERVICE ALARM WHEN HE WAS TRYING TO BOLUS. THE PATIENT STATED WHEN HE REVIEWED THE PUMP HISTORY; THERE WAS NO RECORDED BOLUS DELIVERY. IT WAS NOTED THAT MULTIPLE CALL SERVICE ALARMS HAD OCCURRED IN THE PAST 30 DAYS. 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
    76023 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS VIBE INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1