BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1911153 · Received November 30, 2010

    Report

    Report Number
    2939301-2010-10379
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 22, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 A CRACKED DISPLAY ON THE PATIENT'S ONE TOUCH ULTRALINK METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION: THE REPORTER MENTIONED THAT THE PATIENT WAS ON VACATION IN (B)(6) AND ON (B)(6) 2010, HE NOTICED THAT THE DISPLAY ON HIS ULTRALINK METER WAS CRACKED. DUE TO THE ALLEGED ISSUE, HE CONTINUED TO TAKE HIS USUAL DOSAGE OF MEDICATION. APPROXIMATELY 12 HOURS LATER, HE DEVELOPED SYMPTOMS OF FEELING COLD, SWEATY AND WAS DISORIENTED. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. THE PRODUCT WAS REPLACED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE HOW THE DISPLAY GOT CRACKED, HOW LONG SYMPTOMS LASTED AND WHETHER THE PATIENT TREATED THEMSELVES FOR THE SYMPTOMS. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE CRACKED DISPLAY, HE WAS UNABLE TO TEST AND LATER DEVELOPED SYMPTOM SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3059030

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening