BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1845490 · Received September 27, 2010

    Report

    Report Number
    2939301-2010-08495
    Event Type
    Injury
    Date Received
    September 27, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 15, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    510 (K) # K001109. 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 INACCURATE HIGH READINGS ON THEIR ONE TOUCH ULTRA 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 PATIENT OBTAINED THE FOLLOWING RESULTS ON THE LFS METER ON (B)(6), 2010 AT AROUND 5:27AM "237, 471, 202, 203, 340, 526, 248, 404, 485, 555". THE PATIENT WAS COMPARING METER READINGS TO FEELINGS/ NORMAL RESULTS. THE PATIENT WITHHELD THEIR DOSAGE OF NOVOLOG INSULIN. APPROXIMATELY TWO HOURS LATER, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY, SWEATY, NUMBNESS IN THE HANDS AND FEET, LIGHTHEADEDNESS AND PALE SKIN. THE PATIENT THEN SELF-TREATED WITH 6 UNITS OF NOVOLOG. SHE DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE HIGH READINGS, SHE LATER DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2857382

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R