BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3981575 · Received August 5, 2014

    Report

    Report Number
    2531779-2014-22468
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 28, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 16-AUG-2019 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX AND ALARM HISTORY SHOWED EVIDENCE OF A CALL SERVICE 078 ALARM. DURING TESTING, THE PUMP SUCCESSFULLY COMPLETED THE REWIND, LOAD, AND PRIME STEPS WITHOUT ANY CALL SERVICE ALARMS, WARNINGS OR ISSUES. THE PUMP SUCCESSFULLY COMPLETED A 10 UNIT NORMAL BOLUS TEST WITHOUT ANY ISSUE OR CALL SERVICE ALARMS. THE ORIGINAL COMPLAINT OF A CALL SERVICE ALARM ISSUE WAS NOTED IN THE PUMP HISTORY BUT UNABLE TO BE DUPLICATED DURING INVESTIGATION. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY WAS FOUND TO BE DIM. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 078) ISSUE. 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
    456633 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR