BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 6642637 · Received June 15, 2017

    Report

    Report Number
    3008382007-2017-21568
    Event Type
    Injury
    Date Received
    June 15, 2017
    Report Date
    June 13, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008136
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IN ADDITION, LIFESCAN CONDUCTED AN EVALUATION OF THE TEST STRIP LOT AND CONCLUDED THAT THIS LOT DID NOT BREACH THE THRESHOLDS SET FOR ESCALATION AND NO SYSTEMIC ISSUE WAS OBSERVED. 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) 2017, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO THEIR HEMOGLOBIN A1C RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CALL RECORDING WHICH THE MEDICAL SURVEILLANCE SPECIALIST (MSS) LISTENED TO. THE PATIENT STATED THAT THE ALLEGED INACCURACY BEGAN ON APPROXIMATELY (B)(6) 2017. SINCE THEN THE PATIENT HAD OBTAINED BLOOD GLUCOSE RESULTS OF ¿153, 160, 157, 169, 171 AND 177MG/DL¿ WITH THE SUBJECT METER WHICH THEY FELT WAS INACCURATELY HIGH COMPARED TO THEIR HEMOGLOBIN A1C RESULT OF 6.3. LFS DOES NOT CONSIDER THIS TO BE A VALID COMPARISON. THE PATIENT MANAGES THEIR DIABETES WITH METFORMIN (2000MG PER DAY) AND AN UNSPECIFIED DOSAGE OF VICTOZA. IN RESPONSE TO THE ALLEGED PRODUCT ISSUE THE PATIENT VISITED THEIR DOCTOR¿S OFFICE ON (B)(6) 2017 WHERE THEIR DOCTOR INCREASED THEIR METFORMIN DOSAGE BY AN UNSPECIFIED AMOUNT. AN UNSPECIFIED PERIOD OF TIME AFTER THIS THE PATIENT DEVELOPED SYMPTOMS OF ¿SICK, NAUSEOUS AND COULDN'T WALK OR STAND UP¿. IN RESPONSE TO THESE SYMPTOMS THE PATIENT CALLED THE EMERGENCY MEDICAL SERVICES (EMS) AND WAS TAKEN TO HOSPITAL. IT IS NOT KNOWN WHETHER THE PATIENT¿S BLOOD GLUCOSE WAS TESTED AT THIS POINT, BUT THE PATIENT INFORMED THE CCA THAT THE DOCTOR IN THE HOSPITAL STOPPED THEIR MEDICATION REGIMEN AND KEPT THEM IN OVERNIGHT FOR OBSERVATION. THE PATIENT WAS RELEASED THE NEXT DAY AND WAS PUT ON A NEW MEDICATION REGIMEN OF ¿HALF¿ OF WHAT THEY USED TO TAKE. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO WALK THROUGH A CONTROL SOLUTION TEST. THE PATIENT¿S PRODUCTS WERE REPLACED AND REQUESTED FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY ADVERSE EVENT AFTER TAKING AN INCREASED DOSE OF DIABETES MEDICATION(S) BASED ON ALLEGED INACCURATE HIGH RESULTS OBTAINED WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424752 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4128388 00353885008136

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R