BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3983796 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22576
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 25, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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: 10/14/2014 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: MULTIPLE CS-064 CALL SERVICE ALARMS, WHICH WERE OCCURRING DURING THE LOAD SEQUENCE AND ARE POTENTIALLY RELATED TO THE REPORTED EVENT, WERE OBSERVED IN THE BLACK BOX DATA. DURING INVESTIGATION, INTERMITTENT CS-064 CALL SERVICE ALARMS WERE RECEIVED WHEN THE PISTON CONTACTED THE CARTRIDGE DURING THE LOAD SEQUENCE: THE REPORTED EVENT WAS DUPLICATED. THE PUMP CASE WAS REMOVED, AND NO EVIDENCE OF MOISTURE DAMAGE WAS FOUND INSIDE OF THE PUMP. FURTHER INVESTIGATION REVEALED AN INTERMITTENT INTERNAL MOTOR FAILURE; THIS DEVICE FAILURE DIRECTLY CAUSED THE REPORTED EVENT. THE MOTOR WAS REMOVED FROM THE PUMP, AND THE MOTOR FAILURE WAS DUPLICATED ON A TEST FIXTURE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS EMITTING MULTIPLE CALL SERVICE ALARMS WHEN PERFORMING THE REWIND/LOAD STEPS. 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
    461900 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR