BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 5569297 · Received April 12, 2016

    Report

    Report Number
    2939301-2016-17684
    Event Type
    Injury
    Date Received
    April 12, 2016
    Report Date
    April 7, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THE SUBJECT METER WAS READING INACCURATELY COMPARED TO THEIR FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED INACCURACY FIRST OCCURRED "3 OR 4 DAYS" PRIOR TO THE ALERT DATE OF (B)(6) 2016. AT THIS TIME THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF "158, 144 AND 500MG/DL" WITH THE SUBJECT METER. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (HUMALOG 75/25) AND DENIED MAKING ANY CHANGES TO THEIR NORMAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED PRODUCT ISSUE. THE PATIENT STATED THAT "3 OR 4 DAYS" AFTER THE ALLEGED PRODUCT ISSUE OCCURRED THEY DEVELOPED THE SYMPTOM OF "SHAKING" WHICH THEY ASSOCIATED WITH LOW BLOOD GLUCOSE LEVELS, YET THEY STATED THEIR METER WAS "READING HIGH" AS A RESULT OF THIS SYMPTOM, THE PATIENT SELF-TREATED BY CONSUMING ADDITIONAL FOOD AND/OR DRINK ON THE SAME EVENING THEY DEVELOPED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO WALK THROUGH A RETEST. THE PATIENT'S PRODUCTS WERE REPLACED AND REQUESTED FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS TO HAVE OBTAINED INACCURATE READINGS ON THE SUBJECT METER WHICH LED TO THEM SUFFERING SYMPTOMS WHICH ARE SUGGESTIVE OF SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224764 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3874464

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening