BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2132656 · Received June 17, 2011

    Report

    Report Number
    2939301-2011-04950
    Event Type
    Injury
    Date Received
    June 17, 2011
    Report Date
    June 2, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K062195. 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) 2011 ALLEGING INACCURATE LOW READINGS ON THE PATIENT'S 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 FOLLOWING IS BASED ON THE INITIAL CALL PLACED BY THE REPORTER. THE PATIENT HAD FIRST NOTICED THE ALLEGED ISSUE OVER 3 WEEKS AGO. THE REPORTER MENTIONED THAT THE PATIENT HAD OBTAINED A RESULT OF POSSIBLY A 34 MG/DL AND THE OTHER READINGS OF 40 MG/DL AND A RESULT IN THE 50'S. THE PATIENT DID NOT TAKE ANY ACTION AFTER OBTAINING THE ALLEGEDLY LOW READING. SHORTLY AFTER THE PATIENT EXHIBITED SYMPTOMS OF FEELING WEAK AND HAD A HEADACHE. THE PATIENT WENT AND VISITED THE PHYSICIAN AND OBTAINED A RESULT OF 120 MG/DL ON THE PHYSICIAN'S METER. TIME DIFFERENCE BETWEEN THE PATIENT'S METER AND THE PHYSICIAN'S METER WAS LESS THAN 30 MINUTES FROM ONE ANOTHER. THE PHYSICIAN TREATED THE PATIENT WITH INSULIN. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE INACCURATE LOW READING, THE PATIENT LATER DEVELOPED SYMPTOMS AND HAD TO VISIT THE PHYSICIAN WHERE THEY WERE TREATED BY AN HCP WITH INSULIN FOR A BLOOD GLUCOSE OF 120 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3122753

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R