BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1923944 · Received December 14, 2010

    Report

    Report Number
    2939301-2010-10710
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS 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

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ELEVATED ACCUTNL RESULTS IN THE RISK STRATIFICATION RANGE FOR ONE PATIENT GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND THE PATIENT WAS TRANSFERRED TO THE ICU AND ADMINISTERED HEPARIN VIA AN IV. REPEAT TESTING ON THE ORIGINAL SAMPLE AND SUBSEQUENT TESTING RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2010 ALLEGING INACCURATE HIGH READINGS ON HER ONE TOUCH ULTRA METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT SHE NOTICED THE HIGH READINGS BEGINNING ON (B)(6) 2010. ON (B)(6) 2010 AT 10:00PM, THE PATIENT TESTED HER BLOOD GLUCOSE AND OBTAINED A 225 MG/DL. SHE THEN TOOK 18 UNITS OF RAPID INSULIN. THE FOLLOWING MORNING AT 3:00 AM, THE PATIENT WOKE UP WITH SYMPTOMS OF FEELING SHIVERY AND SWEATY. SHE TESTED HER BLOOD GLUCOSE AND OBTAINED A 56 MG/DL AND DID NOT SELF-TREAT OR SEEK ANY MEDICAL ATTENTION DUE TO ALLEGED ISSUE OR THE REPORTED SYMPTOMS. SHE CLAIMS THAT THE SYMPTOMS LASTED FOR 10 MINUTES. A NORMAL READING FOR THE PATIENT IS BETWEEN 100-140 MG/DL. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT WAS ALLEGEDLY TOOK 12 UNITS OF RAPID INSULIN BASED ON HER BLOOD GLUCOSE OF 225 MG/DL AND THE FOLLOWING MORNING DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3016233

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening