BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3850151 · Received June 4, 2014

    Report

    Report Number
    2531779-2014-15863
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Report Date
    June 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED MULTIPLE 054 CALL SERVICE ALARMS FOLLOWING A LOSS OF PRIME WARNING AND A REPLACE CARTRIDGE ALARM. CALL SERVICE 054 ALARMS ARE CONSISTENT WITH SLEEP ALARMS AND CAN CAUSE THE DISPLAY SCREEN TO BE BLANK FOR SEVERAL MINUTES. A VISUAL INSPECTION OF THE PUMP SHOWED A CRACKED BATTERY COMPARTMENT. THE RETURNED BATTERY CAP WAS ABLE TO FULLY TIGHTEN ON TO THE PUMP WITH NO POWER LOSS. THE PUMP¿S CURRENT DRAWS WERE FOUND TO BE IN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS AND NO POWER LOSS. THE PUMP COVER WAS OPENED AND NO INTERNAL DEFECT WAS FOUND. DURING TESTING, THE DISPLAY SCREEN WAS DIM AND DISCOLORED.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 DATE OF SUBMISSION 06/24/2014: A REVIEW OF THE COMPLAINT SHOWED THAT THIS COMPLAINT WAS REPORTED TWICE IN ERROR AND SHOULD BE A DISPLAY COMPLAINT. THE REPORTABLE COMPLAINT IS ON WAS REPORTED ON REPORT # 2531779-2014-15914.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (POWER ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED TWO ¿CHIRPING NOISES¿ AND THE SCREEN DID NOT POWER ON WHEN BATTERIES WERE INSERTED. 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
    326566 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR