BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3852482 · Received June 5, 2014

    Report

    Report Number
    2531779-2014-15954
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 30, 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/11/2014 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/02/2014 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 VERIFIED THE REPORTED MOTOR REWIND RELATED CALL SERVICE ALARM. THE PUMP POWERED ON WITH THE APPROPRIATE AUDIBLE AND VIBRATORY FEATURES. ALL THE BUTTONS RESPONDED PROPERLY. INVESTIGATION WAS UNABLE TO COMPLETE THE REWIND STEP AND THE 24-HOUR PUMP EXERCISE DUE TO THE REPORTED CALL SERVICE ALARM. PUMP CASING WAS OPENED TO FURTHER INVESTIGATE AND THE INTERNAL MOTOR WAS OPERATING INTERMITTENTLY AND STALLED EASILY. THE REPORTED CALL SERVICE ALARM ISSUE WAS VERIFIED IN THE BLACK BOX AND DUPLICATED IN THE INVESTIGATION.

    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 EMITTED MULTIPLE CALL SERVICE 078, MOTOR REWIND ERROR RELATED ALARMS. 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
    329061 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR