BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 5129675 · Received October 6, 2015

    Report

    Report Number
    2939301-2015-42442
    Event Type
    Injury
    Date Received
    October 6, 2015
    Report Date
    September 30, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DEVICE EVALUATION THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2015 LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) AND ALLEGED THEIR ONE TOUCH ULTRAMINI METER GAVE AN INACCURATE CONTROL SOLUTION RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ISSUE BEGAN ON (B)(6) 2015 IN THE MORNING. THE USER REPORTED THAT THE QUALITY CONTROL TESTS FAILED SPECIFICATION BECAUSE THE RESULTS FELL BELOW THE SPECIFIED RANGE ON THE TEST STRIP VIAL. THE REPORTER CLAIMED OBTAINING CONTROL SOLUTION READING(S) OF "103 MG/DL" WITH THE CONTROL SOLUTION FOR THE SUBJECT LOT BEING 121-161 MG/DL. THE PATIENT MANAGES HER DIABETES WITH PILLS, DIET AND/OR EXERCISE. THE PATIENT CONFIRMED THAT SHE DID NOT MAKE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT CLAIMS SHE DEVELOPED SYMPTOMS OF "BLURRY VISION" AT AN UNKNOWN TIME AFTER THE INACCURATE CONTROL SOLUTION RESULT. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT DUE TO THE PRODUCT ISSUE. NO OTHER DEVICE WAS USED. AT THE TIME OF TROUBLE SHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE; HOWEVER THE PATIENT WAS USING THE INCORRECT CONTROL SOLUTION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660651 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3844932

    Patients

    Seq Age Sex Outcome Treatment
    1