BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3780856 · Received April 30, 2014

    Report

    Report Number
    2531779-2014-11833
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/06/2017 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA REVEALED RECORDS BEGINNING (B)(6) 2016; DATA FROM THE TIME OF THE COMPLAINT HAD BEEN OVERWRITTEN DUE TO CONTINUED PATIENT USE. A REVIEW OF THE AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER¿S PROGRAMMED BASAL RATES. THE PUMP POWERED ON NORMALLY AND PASSED DELIVERY ACCURACY TESTING. THE PUMP WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. INVESTIGATION DID NOT DUPLICATE THE COMPLAINT. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY SCREEN WAS NOTED TO BE DIM/FADED AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. IT WAS REPORTED 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
    260887 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR