BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4880912 · Received July 1, 2015

    Report

    Report Number
    2939301-2015-27228
    Event Type
    Injury
    Date Received
    July 1, 2015
    Report Date
    June 22, 2015
    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
    NY, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED INACCURACY ISSUE OCCURRED ON UNSPECIFIED DATES THROUGHOUT (B)(6). THE PATIENT PROVIDED THE FOLLOWING METER READINGS WHICH WERE OBTAINED FROM THE SUBJECT METER DURING (B)(6): ¿83, 99, 95, 105, 94 AND 102MG/DL¿, AS WELL AS THE FOLLOWING READINGS OBTAINED DURING (B)(6): ¿161, 134, 171, 149 AND 134MG/DL¿. THE PATIENT STATED THAT THEY MANAGE THEIR DIABETES WITH AN UNKNOWN TYPE/DOSAGE OF ORAL MEDICATION AS WELL AS WITH THEIR DIET AND/OR EXERCISE, AND THEY STATED THAT THEY TOOK A ¿BLOOD SUGAR PILL¿ DURING THE MORNING OF (B)(6) 2015 IN RESPONSE TO THE ALLEGED SUBJECT METER RESULTS. AT AN UNKNOWN TIME AFTER THE PRODUCT ISSUE STARTED THE PATIENT DEVELOPED THE SYMPTOM OF ¿SWEATING¿, AS WELL AS STATING THAT THEY FELT LIKE ¿SOMETHING WAS WRONG¿. AN UNSPECIFIED PERIOD OF TIME AFTER THIS, THE PATIENT SELF-TREATED WITH GLUCOSE TABLETS/GEL. NO FURTHER BLOOD GLUCOSE READINGS WERE TAKEN ON ANY OTHER DEVICE AT THIS TIME. AT THE TIME OF TROUBLESHOOTING THE CSR NOTED THAT UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND AN APPROVED SAMPLE SITE WAS BEING USED. HOWEVER, THE RESULTS WHICH WERE OBTAINED WERE OBTAINED GREATER THAN 20 MINUTES FROM EACH OTHER. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: ALTHOUGH THE METER READINGS OBTAINED DO NOT MEET LFS PRECISION CRITERIA, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429404 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3721130

    Patients

    Seq Age Sex Outcome Treatment
    1