BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2042676 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02859
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 USER/ PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE HIGH READING ON THEIR ONE TOUCH ULTRALINK METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL TO GET A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. THE PATIENT MENTIONED THAT HE "CRASHED" ON THE NIGHT OF (B)(6) 2011 AND HAD TO CONTACT EMS. THE PATIENT MENTIONED THAT WHEN THE PARAMEDICS TESTED THE PATIENT ON THE EMS' METER HIS BLOOD GLUCOSE WAS 33 MG/DL AND THE PATIENT'S LFS METER READ 271 MG/DL. THE PATIENT WAS UNABLE / UNWILLING TO FURTHER TROUBLESHOOTING, SINCE THE PATIENT HAD TO BE AT WORK. PRODUCT WAS REPLACED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, "NORMAL" READING FOR THE PATIENT, READINGS PRIOR TO THE EVENT, EVENTS LEADING TO THE EVENT, DETAILS ON SYMPTOMS, TREATMENT AND WHETHER THE PATIENT WAS TAKEN TO THE HOSPITAL. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READING, HE DEVELOPED SYMPTOMS AND HAD TO CONTACT EMS FOR ASSISTANCE.

    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 58 YR Life Threatening| R