BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1894544 · Received November 9, 2010

    Report

    Report Number
    2939301-2010-09769
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/02/2010. 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 BATTERY WAS INSTALLED INCORRECTLY. 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

    INCORRECT PT SELECTED BY USING THE BARCODE READER.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE MEDICAL SURVEILLANCE SPECIALIST WAS UNABLE TO REACH THE PATIENT BY PHONE. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE STARTED ON (B)(6) 2010 AT 9:00AM. THE CCA NOTED THAT THE PATIENT MANAGES HER DIABETES WITH INSULIN. THE PATIENT INFORMED THE CCA THAT SHE TAKES 1 UNIT OF HUMALOG INSULIN FOR EVERY 8 GRAMS OF CARBOHYDRATES SHE HAS. THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. HOWEVER, BETWEEN 12 AND 4:00PM THAT SAME DAY, THE PATIENT CLAIMED SHE BEGAN TO FEEL TIRED, SHAKY AND HER HEARING WAS AFFECTED. THE PATIENT REPORTED TREATING HERSELF WITH 2 UNITS OF INSULIN AT AN UNSPECIFIED TIME ON (B)(6) 2010. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER'S BATTERY DID NOT NEED TO BE REPLACED PER THE OWNER'S BOOKLET RECOMMENDATIONS. IN ADDITION, THE CCA CONFIRMED THAT THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE ALLEGED POWER ISSUE REMAINED UNRESOLVED. 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 A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2993639

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R