BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1853181 · Received October 5, 2010

    Report

    Report Number
    2939301-2010-08765
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 18, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. A 510(K) # IS K061118.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 AT 10 AM. THE PATIENT ADVISED THE CCA SHE DOES NOT TAKE MEDICATION TO MANAGE HER DIABETES; HOWEVER, CONTINUED TO FOLLOW HER USUAL MANAGEMENT ROUTINE DESPITE THE ALLEGED ISSUE. AN HOUR AFTER THE START OF THE ALLEGED PRODUCT ISSUE, THE PATIENT CLAIMED SHE FELT A SYMPTOM OF THE SHAKES. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER AND THE CORRECT TEST STRIPS WERE BEING USED FOR TESTING. THE CCA ADVISED THE PATIENT THE BATTERIES NEEDED TO BE REPLACED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 414 MG/DL AND 119 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3018271

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening