BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3863668 · Received June 10, 2014

    Report

    Report Number
    2531779-2014-16280
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/07/2014 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP POWERED ON TO THE ¿VERIFY¿ SCREEN IN ACCORDANCE WITH NORMAL OPERATION WITH AUDIO TONES AND VIBRATIONS FUNCTIONAL. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OCCURRING. THE RETURNED PUMP WAS ABLE TO CORRECTLY CALCULATE AN EZBG BOLUS AND AN EZCARB BOLUS. THE COMPLAINT THAT THE PUMP WAS INCORRECTLY CALCULATING CORRECTION BOLUSES WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION.

    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 HISTORY/SETTINGS ISSUE. THE REPORTER INDICATED THAT THE PATIENT¿S HEALTH CARE PROVIDER ALLEGED THAT THE PUMP¿S DOWNLOAD SHOWED INCORRECT CALCULATIONS FOR RECOMMENDED CORRECTION BOLUSES. 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
    337590 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR