BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 2943434 · Received February 5, 2013

    Report

    Report Number
    2531779-2013-01476
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    August 23, 2012
    Report Date
    January 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 03/08/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: A SINGLE COMPONENT FAILURE ON THE PRINTED CIRCUIT BOARD WAS CONFIRMED: TESTING WAS UNABLE TO DUPLICATE COMPLAINT OF ELECTRIC SHOCK. NO PHYSICAL OR MOISTURE DAMAGE WAS OBSERVED TO THE BATTERY COMPARTMENT OR BATTERY CAP; THE BATTERY CAP FASTENS SECURELY. THE PUMP BOOTS UP WITH TWO BEEPS, VIBRATION, AND A BLANK DISPLAY. AFTER SEVERAL MINUTES, THE DISPLAY IS STILL BLANK AND PUMP IS VIBRATING. PUMP WAS OPENED AND A TEST DISPLAY WAS INSERTED WITH NO IMPROVEMENT. UNABLE TO PERFORM ALL TESTING STEPS DUE TO BLANK DISPLAY AND FAILURE. REVIEW OF THE TDD SHOWS PUMP WAS DELIVERING ACCURATELY ON THE LAST FULL DAY) USED BY THE PATIENT AND REFLECTS THEIR ACTIVE BASAL PROGRAM. THE BLACK BOX CONFIRMS SEVERAL CALL SERVICE ALARMS OCCURRING ON (B)(6) 2012; NO ACTIVITY RELATED TO THE HOT BATTERY WAS OBSERVED IN THE BLACK BOX. NO ABNORMAL BATTERY DRAIN WAS OBSERVED. THE PUMP WAS OPENED AND EVALUATED; UNABLE TO PROGRAM THE SLAVE PROCESSOR. NO INTERNAL MOISTURE DAMAGE WAS OBSERVED AND NO "SHOCK" WAS GIVEN WHEN BATTERY WAS REMOVED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013, ALLEGING WHEN REPLACING THE BATTERY, THE PATIENT NOTED THE BATTERY HAD BECOME VERY HOT. THE PATIENT STATED THAT WHEN THE NEW BATTERY WAS PLACED INTO THE PUMP, THE DISPLAY REMAINED DARK. THE PATIENT FURTHER REPORTED THAT WHEN THE HOT BATTERY WAS REMOVED FROM THE PUMP, SHE GOT AN ELECTRICAL SHOCK FROM THE BATTERY. THE REPORT OF THE ELECTRICAL SHOCK IS NOT CONSIDERED TO BE A REPORTABLE EVENT BECAUSE THERE WAS NO ALLEGATION OF HOSPITALIZATION OR MEDICAL/THIRD PARTY INTERVENTION REQUIRED DUE TO THE SHOCK. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER ALLEGED THE BATTERY IN THE PUMP HAD BECOME HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48411 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS VIBE INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1