BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4852410 · Received June 18, 2015

    Report

    Report Number
    2939301-2015-25237
    Event Type
    Injury
    Date Received
    June 18, 2015
    Report Date
    June 12, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1. THE LAY USER/PATIENTS METER AND TEST STRIPS HAVE 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 REPRODUCED. THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE REPORTED ISSUE COULD NOT BE CONFIRMED HOWEVER A SECONDARY ISSUE WAS NOTED; THE TEST VIAL LABEL WAS FOUND TO BE CONTAMINATED WITH AN UNKNOWN SUBSTANCE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATER 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, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THEIR ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT WAS UNSURE WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿179, 126 AND 65MG/DL¿ ON THE SUBJECT METER, OBTAINED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES THEIR DIABETES WITH PILLS, DIET AND EXERCISE. THE PATIENT REPORTED CONSUMING MORE FOOD AND DRINK. THE PATIENT REPORTED DEVELOPING A SYMPTOM OF ¿SHAKY¿ 20-25 MINUTES AFTER THE ALLEGED INACCURACY BEGAN. THE PATIENT DENIED RECEIVING ANY FURTHER TREATMENT. AT THE TIME OF TROUBLESHOOTING THE CCA FOUND THAT THE TEST STRIPS HAD BEEN STORED IMPROPERLY (PER OWNER¿S BOOKLET RECOMMENDATION). REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED A SERIOUS SYMPTOM ASSOCIATED WITH HYPOGLYCEMIA AFTER THE ALLEGED INACCURACY BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397528 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3603353

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R