BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 5252773 · Received November 27, 2015

    Report

    Report Number
    2939301-2015-50977
    Event Type
    Injury
    Date Received
    November 27, 2015
    Report Date
    November 19, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. LIFESCAN CONDUCTED AN EVALUATION OF THE TEST STRIP LOT AND CONCLUDED THAT THIS LOT DID NOT BREACH THE THRESHOLDS SET FOR ESCALATION AND NO SYSTEMATIC 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) 2015, THE PATIENT / LAY USER CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRAMINI METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW UP CALL WITH THE PATIENT. THE PATIENT STATED THAT THE ALLEGED INACCURACY BEGAN AT AN UNSPECIFIED TIME ON (B)(6) 2015. AT THIS TIME THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "199, 251, 190, 173, 234, 171, 145, 165, 142 AND 143MG/DL" WITH THE SUBJECT METER GREATER THAN 20 MINUTES FROM ONE ANOTHER. THE PATIENT INFORMED THE CCA THAT THEY MANAGE THEIR DIABETES WITH A COMBINATION OF MEDICATIONS (2X 100MG METFORMIN, UNSPECIFIED DOSAGE OF LEVEMIR, 5MG GLIPIZIDE AND 20MG SIMVASTATIN PER DAY), AND PRIOR TO THE ALLEGED PRODUCT ISSUE OCCURRING THE PATIENT HAD ALLEGEDLY BEEN ON A "LOW CARBOHYDRATE" DIET. THE PATIENT STATED THAT AN UNSPECIFIED TIME LATER THEY DEVELOPED THE SYMPTOM OF "EXTREME THIRST" WHICH THEY ASSOCIATED WITH HIGH BLOOD GLUCOSE LEVELS. IN RESPONSE TO THIS SYMPTOM THE PATIENT SELF-TREATED BY CONSUMING "WATER" AND HAVING FOOD AND/OR DRINK IMMEDIATELY. NO MEDICAL TREATMENT WAS REQUIRED AS A RESULT OF THIS ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, IT WAS CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY, AND THE PRODUCTS WERE REQUESTED BACK FOR EVALUATION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT OBTAINED THE ALLEGED SUBJECT METER RESULTS IN A TIME EXCEEDING 20 MINUTES, AND THEREFORE THE INACCURACY CANNOT BE CONFIRMED, THIS COMPLAINT IS BEING REPORTED FOR THE FOLLOWING REASON: THE PATIENT CLAIMS TO HAVE SUFFERED SYMPTOMS INDICATIVE OF SERIOUS INJURY AFTER THE ALLEGED INACCURATE ERRATIC RESULTS WERE OBTAINED AND THE SUBJECT METER COULD NOT BE RULED OUT AS THE CAUSE/CONTRIBUTOR TO THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783050 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3745334

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening