BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SURESTEP METER

    MDR report key: 1915632 · Received December 6, 2010

    Report

    Report Number
    2939301-2010-10541
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 2, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 02/11/2011. THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4).510 (K) # IS K942455. 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 (B)(4) ON (B)(6) 2010 ALLEGING METER WILL NOT TURN ON WITH POWER BUTTON OR STRIPS. THE PATIENT MENTIONED THAT SHE NOTICED THE ALLEGED ISSUE APPROXIMATELY 2-3 WEEKS AGO. THE PATIENT HAD REPLACED THE BATTERY AND ISSUE STILL PERSISTED. THE PATIENT TOOK THEIR USUAL DOSAGE OF DIABETES MEDICATION AFTER THE ALLEGED ISSUE BEGAN. APPROXIMATELY 5-7 DAYS AFTER THE ALLEGE DISUSE BEGAN, THE PATIENT HAD FELT WEAK, TIRED, CLAMMY AND EXPERIENCED BLURRED VISION DUE TO THE ALLEGED ISSUE. DUE TO THE ALLEGED ISSUE, THE PATIENT WENT TO THE ER AND WAS TREATED WITH 5 BOTTLES OF FLUIDS FOR DEHYDRATION. THE PATIENT'S BLOOD GLUCOSE WAS MONITORED IN THE ER AND IN THE LAB OVER 2 HOURS APART AND THE READINGS WERE AS FOLLOWS ON EITHER THE LAB AND THE HOSPITAL DEVICE : "24.?, 26.?, 17.?, 15.?". IT IS UNKNOWN WHICH DEVICE READ WHAT READING.WHILE TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT HAD BEEN USING EXPIRED TEST STRIPS. USING EXPIRED TESTING SUPPLIES MAY LEAD TO FALSE BLOOD GLUCOSE READINGS. ISSUE WAS NOT RESOLVED VIA TROUBLESHOOTING.PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER NOT POWERING ON, SHE DEVELOPED SYMPTOMS OF A SERIOUS INJURY AND HAD TO RECEIVE FLUIDS IN THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SURESTEP METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2640353

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R