BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1831292 · Received September 10, 2010

    Report

    Report Number
    2939301-2010-07714
    Event Type
    Injury
    Date Received
    September 10, 2010
    Report Date
    August 13, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS OBTAINED DURING A FOLLOW-UP CALL TO THE PATIENT ON EITHER SEPTEMBER 13 OR SEPTEMBER 14, 2010. THE PATIENT STATED THAT THE REPORTED METER TO OTHER METER COMPARISON WAS PERFORMED ON THE MORNING OF (B)(6), 2010. THE PATIENT INFORMED THE CSR THAT HE TESTS HIS BLOOD GLUCOSE 1X/DAY AND MANAGES HIS DIABETES BY TAKING A SET DOSE OF INSULIN 3X/DAY (WITH MEALS). THE PATIENT REPORTED THAT HE TOOK HIS USUAL DOSE OF INSULIN ON THE MORNING OF (B)(6), 2010 BASED ON THE "165 MG/DL" READING OBTAINED ON THE FREESTYLE METER. THE PATIENT DENIED DEVELOPING SYMPTOMS OR RECEIVING MEDICAL TREATMENT AS A RESULT OF THE ALLEGED INACCURATE RESULT OBTAINED WITH THE SUBJECT METER. THE PATIENT CONFIRMED HE WAS CONCERNED THAT THE SUBJECT METER WAS READING INACCURATELY HIGH NOT ONLY IN COMPARISON TO ANOTHER DEVICE, BUT ALSO TO HIS FEELINGS (DID NOT FEEL LIKE HE WAS HIGH) AND PAST RESULTS. THE NEW INFORMATION PROVIDED BY THE PATIENT CHANGES THE CLASSIFICATION OF THIS COMPLAINT. THE COMPLAINT IS NO LONGER AN ADVERSE EVENT; HOWEVER, IS STILL BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS' ACCURACY CRITERIA.

    Additional Manufacturer Narrative · 1

    THE 510K # 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

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. ON AN UNSPECIFIED DATE/TIME, THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF "250 MG/DL" WITH THE SUBJECT METER AND "165 MG/DL" ON ANOTHER DEVICE (FREESTYLE), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30%. IT IS NOT KNOWN WHAT MEDICATIONS, IF ANY, THE PATIENT TAKES TO MANAGE HIS DIABETES. IT IS ALSO NOT KNOWN IF THE PATIENT MADE ANY ADJUSTMENTS TO HIS DIABETES MANAGEMENT AS IN RESPONSE TO THE ALLEGED INACCURATE RESULT. THE CSR NOTED THAT THE PATIENT CLAIMED HE HAD BEEN HAVING "HYPOGLYCEMIA" EVENTS LATELY. IT IS NOT KNOWN IF THE SYMPTOMS OF "HYPOGLYCEMIA" BEGAN PRIOR TO OR AFTER THE ALLEGED ISSUE BEGAN. IT IS ALSO NOT KNOWN IF THE PATIENT TESTED WITH THE SUBJECT METER PRIOR TO, AT THE TIME, OR AFTER THE ONSET OF SYMPTOMS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THERE IS A POSSIBILITY THAT THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER OBTAINING ALLEGED INACCURATE RESULTS WITH THE SUBJECT METER.

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2005. IT WAS REPORTED THAT THE IPG WOULD NO LONGER COMMUNICATE WITH THE PROGRAMMER OR CHARGER. THE SYSTEM WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S DEVICE ON (B)(6) 2007. FOLLOW UP ON THE PT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE EXPLANTED IPG WAS NOT RETURNED TO ANS FOR EVAL. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2967657

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening