BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1883624 · Received October 26, 2010

    Report

    Report Number
    2939301-2010-09480
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 7, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K073231. 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

    THE LAY REPORTER CONTACTED LFS ON (B)(6) 2010 ALLEGING INACCURATE HIGH READINGS ON THE PATIENT'S ONE TOUCH ULTRALINK METER. THE REPORTER MENTIONED THAT THE PATIENT TESTED ON HER LFS METER ON (B)(6) 2010 AT 9:30AM AND OBTAINED A 437 MG/DL AND LESS THAN 30 MINUTES LATER TESTED ON AN ACCUCHECK METER AND OBTAINED A 354 MG/DL. THE PATIENT WENT AND TOOK HER USUAL DOSAGE OF MEDICATION (NOVOLOG BASED ON A SLIDING SCALE) AFTER TESTING ON THE LFS METER. APPROXIMATELY AN HOUR AND FIFTEEN MINUTES LATER THE PATIENT FELT SHAKY, AND FELT LIKE FALLING OVER. THE HOME HEALTH NURSE THEN TREATED THE PATIENT WITH GLUCOSE TABLETS/ GLUCOSE GEL. THE PATIENT WAS NOT RETESTED. REPORTER DID NOT HAVE PRODUCTS AVAILABLE TO FURTHER TROUBLESHOOT. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT THE PATIENT HAD TO RECEIVE MEDICAL TREATMENT FOR HYPOGLYCEMIA AFTER OBTAINING TAKING INSULIN BASED ON AN ALLEGED HIGH READING ON THEIR LSF METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening| R