BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242559 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11708
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/15/2013. DEVICE EVALUATION:THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/30/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP HISTORY WAS REVIEWED AND SHOWED THE LAST BOLUS WAS RECORDED ON 06/18/2013 AND THE LAST BASAL DELIVERY WAS RECORDED ON 06/19/2013. THERE ARE NO ALARMS RELATED TO THE COMPLAINT NOTED IN THE ALARM HISTORY; ONLY TYPICAL USAGE OBSERVED. THE TOTAL DAILY DOSES ADDED UP CORRECTLY. THE PUMP SUCCESSFULLY COMPLETED A 29 HOUR FLOW ACCURACY TEST WITH NO ALARMS OCCURRING DURING TESTING. THE PUMP WAS FOUND TO BE OPERATING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THE DISPLAY SCREEN WAS DISCOLORED. A TEST SCREEN WAS INSERTED AND WAS FOUND TO FUNCTION PROPERLY. THE COMPLAINT WAS NOT ABLE TO BE DUPLICATED DURING THE INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP HAD COMPLETELY FAILED. THE REPORTER INDICATED USING A BACK UP PLAN AS PROVIDED BY A HEALTH CARE PROVIDER. ANIMAS ATTEMPTED TO FOLLOW UP WITH THE REPORTER FOR ADDITIONAL INFORMATION BUT WAS UNSUCCESSFUL AT THIS TIME. THERE WAS NO INDICATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PUMP HAD FAILED REQUIRING THE PATIENT TO SEEK A BACK UP TREATMENT METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342350 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR