BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1862377 · Received October 8, 2010

    Report

    Report Number
    2939301-2010-08943
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A 510 (K) # IS K021819. 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) 2010 ALLEGING THAT THEIR METER DISPLAYS "PC" BEFORE OR AFTER INSERTING A TEST STRIP INTO THE METER AND WAS UNABLE TO TEST THEIR BLOOD GLUCOSE. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. THE FOLLOWING IS BASED ON THE INITIAL CALL PLACED ON (B)(6) 2010: THE REPORTED ISSUE BEGAN ON (B)(6) 2010 AT AROUND 12:30-1:00 PM. APPROXIMATELY 27 HOURS LATER, HE DEVELOPED SYMPTOMS OF FEELING SHAKY AND SWEATY. HE ATE MORE FOOD/DRINK. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE PATIENT DENIED ANY MISUSE OF THE PRODUCT. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. THE ALLEGED ISSUE WAS NOT RESOLVED AND PRODUCT WAS REPLACED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, READINGS PRIOR TO THE INCIDENT AND HOW LONG SYMPTOMS LASTED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT WAS UNABLE TO TEST DUE TO THE REPORTED ISSUE AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3027246

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening| R