BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3896142 · Received June 26, 2014

    Report

    Report Number
    2939301-2014-15454
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    June 16, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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 (07/16/2014)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED ON 07/16/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 07/16/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND AND THE PRIMARY COMPLAINT COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE ONETOUCH ULTRALINK METER IS GIVING INACCURATE HIGH READING OF ¿219 MG/DL¿ COMPARED TO ANOTHER METER READING OF ¿255 MG/DL.¿ THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2014, THE PATIENT TOOK 5 UNITS OF APIDRA INSULIN BASED ON THE ALLEGED READING OF ¿219 MG/DL.¿ WITHIN 45 MINUTES, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF ¿SHAKES AND TINGLING FEELING.¿ THERE WAS NO REPORT OF ANY REQUIRED MEDICAL INTERVENTION AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THE METER TO OTHER METER COMPARISON WAS PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS IS WITHIN THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE UNIT OF MEASUREMENT WAS SET CORRECTLY AT THE TIME OF TESTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER SHE TOOK INSULIN BASED ON THE REPORTED LFS METER READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373307 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3606093

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening