BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1955357 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00310
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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

    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. 510(K) # IS K062195.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A 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 THAT HER ONETOUCH ULTRA METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS ON (B)(6), 2011 TO OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT HER TESTING FREQUENCY IS TWICE DAILY AND MANAGES HER DIABETES WITH ORAL MEDICATIONS OF METFORMIN (850MG 3X DAILY) AND ACTOS (45MG 1X DAILY). THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6), 2010 AT 8:00PM. THE PATIENT REPORTED OBTAINING INACCURATE ERRATIC READINGS OF "143, 163, AND 93 MG/DL" WITH THE SUBJECT METER, PERFORMED GREATER THAN 20 MINUTES OF EACH OTHER. PRIOR TO OBTAINING THE ALLEGED ERRATIC READINGS, THE PATIENT INDICATED SHE ADMINISTERED HER USUAL ORAL DOSE OF DIABETES MEDICATIONS AT 5:30PM THAT DAY. THE PATIENT CLAIMED SHE WAS FEELING NERVOUS, SWEATY, AND LIGHTHEADED 2 ½ HOURS AFTER THE ALLEGED ISSUE BEGAN; HOWEVER SHE COULD NOT CONFIRM WHETHER THE SYMPTOMS WERE ASSOCIATED AS HIGH OR LOW BLOOD SUGAR SYMPTOMS. THE PATIENT CONFIRMED SHE DID NOT RECEIVE ANY MEDICAL TREATMENT DUE TO THE ALLEGED SYMPTOMS, BUT MENTIONED THAT HER SYMPTOMS CLEARED UP ABOUT AN HOUR LATER. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THAT THE PATIENT TESTED ON AN APPROVED SAMPLE SITE AND THE UNIT OF MEASURE ON THE SUBJECT METER WAS SET CORRECTLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT 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. 3052607

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening