BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3934285 · Received July 15, 2014

    Report

    Report Number
    2531779-2014-20043
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    July 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/26/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND RECORDS OF THE REPORTED MOTOR RELATED CALL SERVICE ALARMS. THE PUMP POWERED UP TO THE VERIFY SCREEN WITH AUDITORY AND VIBRATORY FEATURE. ALL THE BUTTONS RESPONDED PROPERLY. DURING THE REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE THE PUMP EMITTED MOTOR RELATED CALL SERVICE ALARMS. THE REPORTED CALL SERVICE ALARM WAS VERIFIED IN THE BLACK BOX AND DUPLICATED IN THE INVESTIGATION. THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED FROM THE THREADS TO THE BASE SEAL AND MOISTURE WAS EVIDENT INSIDE THE COMPARTMENT. A LEAK TEST SHOWED A LEAK WHERE THE CRACK WAS LOCATED. THE PUMP CASING WAS OPENED TO FURTHER INVESTIGATE AND MOISTURE CONTAMINATION WAS FOUND AROUND THE MOTOR WIRE CONNECTOR ON THE PRINTED CIRCUIT BOARD.

    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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 078) ISSUE. REPORTEDLY, THE PUMP ALARMED FOR MOTOR REWIND ERROR MULTIPLE 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
    413970 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR