BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3900771 · Received June 27, 2014

    Report

    Report Number
    2531779-2014-18583
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/16/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA REVEALED RECORDED CS 078-0008 AND CS 064-0008 CALL SERVICE ALARMS. NO ALARMS WERE DUPLICATED DURING TESTING. UNRELATED TO THE COMPLAINT, THE PUMP BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED, AND CORROSION DUE TO MOISTURE WAS FOUND INSIDE THE BATTERY COMPARTMENT. THE BOLUS BUTTON COVER WAS ALSO TORN. THE BOLUS BUTTON COVER WAS REMOVED AND CORROSION WAS FOUND ON THE BUTTON CONTACTS. THE PUMP CASE WAS REMOVED AND ADDITIONAL CORROSION DUE TO MOISTURE WAS FOUND ON AN INTERNAL COMPONENT.

    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. IT WAS REPORTED THAT THE PUMP EMITTED A CS 078 CALL SERVICE ALARM THREE TIMES IN THIRTY DAYS. IT WAS ALLEGED THAT THE USER BLOOD GLUCOSE (BG) READING WAS GREATER THAN 250 MG/DL; HOWEVER, THE BG READING DID NOT EXCEED 500 MG/DL. NO SYMPTOMS OF HYPERGLYCEMIA WERE REPORTED. THE ALLEGED BG EXCURSION DOES NOT MEET ANIMAS CRITERIA FOR A SERIOUS INJURY AND IS THEREFORE NOT REPORTABLE AS AN ADVERSE EVENT. 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
    378044 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR