BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3931822 · Received July 14, 2014

    Report

    Report Number
    2531779-2014-19864
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    July 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    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. 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA SHOWED OCCURRENCES OF THE REPORTED ALARM FOR SOFTWARE RELATED ISSUE. THE PUMP POWERED ON FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT ANY INCIDENCES. PUMP CASING WAS OPENED AND CORROSION WAS FOUND ON INTERNAL COMPONENTS. THE REPORTED CALL SERVICE ALARM ISSUE WAS VERIFIED IN THE BLACK BOX BUT NOT DUPLICATED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 088) ISSUE. REPORTEDLY, THE REPORTED CALL SERVICE ALARM HAD OCCURRED MORE THAN 3 TIMES IN THE PAST 30 DAYS. 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
    411345 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR