BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3050030 · Received April 10, 2013

    Report

    Report Number
    3008382007-2013-07467
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY HIGH COMPARED TO A LABORATORY DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN IN THE MORNING ON (B)(6) 2013. THE PATIENT'S TESTING FREQUENCY IS NOT KNOWN AND OTHER THAN DIABETES, IT IS NOT CLEAR IF THE PATIENT SUFFERS FROM OTHER HEALTH CONDITIONS. ACCORDING TO THE CSR'S DOCUMENTATION, PRIOR TO THE START OF THE ALLEGED ISSUE (IN (B)(6) 2013), THE PATIENT'S BLOOD GLUCOSE REPORTEDLY DROPS IN THE MIDDLE OF THE NIGHT CAUSING HER TO FALL; HOWEVER, THE PATIENT'S PREVIOUS BLOOD GLUCOSE READINGS AND HER ACTIONS IN RESPONSE TO HER PREVIOUS READINGS ARE NOT KNOWN. ACCORDING TO THE CSR'S DOCUMENTATION, SINCE (B)(6) 2013, THE PATIENT REPORTEDLY RECEIVED FOOD/DRINK AS TREATMENT FROM A HEALTH CARE PROFESSIONAL, SHE WAS HOSPITALIZED IN (B)(6), AND SHE HAD OBTAINED A BLOOD GLUCOSE READING OF "50MG/DL" WITH THE HOSPITAL'S METER (DATE/TIME NOT SPECIFIED). THE PATIENT'S BLOOD GLUCOSE READINGS WITH THE SUBJECT METER PRIOR TO GOING TO THE HOSPITAL ARE NOT KNOWN, THE REASON FOR GOING TO THE HOSPITAL IS NOT CLEAR, AND THE PATIENT'S MEDICAL DIAGNOSIS PRIOR TO BEING DISCHARGED FROM THE HOSPITAL IN JANUARY AND FEBRUARY ARE NOT SPECIFIED. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING OF "158MG/DL" WITH THE SUBJECT METER AND A READING OF "100MG/DL" WITH A LABORATORY DEVICE, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BETWEEN THE TESTS THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH HUMULIN R INSULIN (VIA INSULIN PUMP); HOWEVER, IT IS NOT CLEAR WHAT ACTION THE PATIENT TOOK IN RESPONSE TO THE ALLEGED METER ISSUE. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S BOOKLET) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO EVIDENCE THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY BECAUSE, THE PATIENT REPORTEDLY SUFFERED SYMPTOMS PRIOR TO THE ALLEGED PRODUCT ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151980 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3325862

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR