BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1696363 · Received May 19, 2010

    Report

    Report Number
    2939301-2010-03952
    Event Type
    Injury
    Date Received
    May 19, 2010
    Date of Event
    May 2, 2010
    Report Date
    May 7, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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

    ON (B) (6), 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA METER WAS DISPLAYING INACCURATE ERRATIC RESULTS. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN AT APPROXIMATELY 10:00 PM ON (B) (6), 2010. THE PATIENT CLAIMED, HE TESTED HIS BLOOD GLUCOSE ON THE SUBJECT METER AND OBTAINED RESULTS OF "91, 234, 147 AND 231 MG/DL," PERFORMED WITHIN 20 MINUTES APART FROM EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/OR <=20 MG/DL. THE CCA DOCUMENTED THAT THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF ADJUSTER). THE PATIENT CLAIMED THAT HE CONTINUED WITH HIS USUAL DOSE OF MEDICATION DESPITE THE ALLEGED METER ISSUE. A MONTH AFTER THE ALLEGED METER ISSUE BEGAN, THE PATIENT CLAIMED THAT HE BECAME SWEATY, SHAKY, DIZZY, AND NAUSEATED." AT APPROXIMATELY 12:30 PM ON (B) (6), 2010, THE PATIENT REPORTED THAT HE TREATED HIMSELF WITH A GLUCOSE TABLET/GEL. THE PATIENT DENIED USING ANY OTHER METER TO TEST HIS BLOOD GLUCOSE. DURING THE TROUBLESHOOTING SESSION, THE CCA VERIFIED THAT THE PATIENT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM A QUALITY CONTROL TEST. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS CLASSIFIED AS MDR-REPORTABLE DUE TO THE FOLLOWING CONCLUSION(S): THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED INACCURATE ERRATIC READINGS ON THE SUBJECT METER AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening