BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3160092 · Received June 10, 2013

    Report

    Report Number
    2531779-2013-08018
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/07/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/15/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP HISTORY WAS REVIEWED AND SHOWED THE PUMP REBOOTED. NO PHYSICAL DAMAGE WAS FOUND TO THE RETURNED BATTERY CAP OR BATTERY COMPARTMENT; THE RETURNED BATTERY CAP FASTENED SECURELY AND HELD POWER TO THE PUMP. THE RETURNED BATTERY CAP WIDTH AND HEIGHT MEASUREMENTS ARE ALL WITHIN SPECIFICATION. DURING EVALUATION, NO INTERMITTENT POWER ISSUES WERE EXPERIENCED WITH THE RETURNED BATTERY CAP OR PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH THE RETURNED BATTERY CAP; NO POWER INTERRUPTIONS WERE DUPLICATED; THE PUMP WAS STILL DELIVERING AT THE CONCLUSION OF TESTING. THE PUMP WAS OPENED AND NO INTERNAL MOISTURE DAMAGE, LOOSE COMPONENTS OR INTERMITTENT CONNECTIONS WERE IDENTIFIED INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THE DISPLAY SCREEN WAS DISCOLORED. A TEST SCREEN WAS INSERTED AND WAS FOUND TO FUNCTION PROPERLY WITH NO VISIBLE SIGNS OF DISCOLORATION. THE INTERMITTENT POWER ISSUE WAS NOTED IN THE HISTORY BUT COULD NOT BE DUPLICATED DURING THE INVESTIGATION. 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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE PUMP REPORTEDLY LOST POWER WITHOUT USER INTERVENTION AND DISPLAY WAS BLANK. A REVIEW OF THE ALARM HISTORY INDICATED THE PATIENT DID NOT RECEIVE LOW BATTERY OR REPLACE BATTERY ALARMS PRIOR TO POWER LOSS. 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
    260252 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR