BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 6025355 · Received October 13, 2016

    Report

    Report Number
    3008382007-2016-52970
    Event Type
    Injury
    Date Received
    October 13, 2016
    Report Date
    October 1, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER 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) 2016 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA 2 METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE CSR DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT STATED THAT THE ALLEGED METER ISSUE BEGAN APPROXIMATELY 1 MONTH PRIOR TO CONTACTING LFS. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "204, 162, 138 AND 380 MG/DL WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR PRECISION. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH INSULIN (UNKNOWN TYPE; SELF-ADJUSTER). THE PATIENT TESTS HIS BLOOD GLUCOSE APPROXIMATELY 3 TIMES PER DAY. THE PATIENT DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED METER ISSUE. AT AN UNKNOWN TIME RELATIVE TO THE START OF THE METER ISSUE THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS OF "SWEATING" AND "BLURRY VISION" AND "ALMOST PASSED OUT". HE ASSOCIATED THESE SYMPTOMS WITH HYPOGLYCEMIA. THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE SYMPTOMS. THE PATIENT STATED A BLOOD GLUCOSE READING WAS TAKEN ON HIS UNCLES METER WHILE HE WAS SYMPTOMATIC BUT HE WAS UNABLE TO REMEMBER THE RESULTS. DURING TROUBLESHOOTING THE CSR CONFIRMED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THAT THE TEST STRIPS WERE STORED PROPERLY WITH AN INTACT VIAL AND THAT THEY HAD NOT EXPIRED NOR EXCEEDED THEIR DISCARD DATE. THE PATIENTS TESTING PROCESS WAS CONFIRMED AS CORRECT AND SAMPLES WERE TAKEN FROM THE CORRECT SAMPLE SITES. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. PRODUCTS WERE REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF ACUTE METABOLIC DISTRESS FROM HYPOGLYCEMIA AFTER OBTAINING THE ALLEGED INACCURATE RESULTS WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676515 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4033323

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening