BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1900788 · Received November 16, 2010

    Report

    Report Number
    2939301-2010-09952
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 25, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) ATTEMPTED TO CONTACT THE PATIENT FOR A FOLLOW UP CALL ON (B)(6) 2010, BUT WAS UNABLE TO REACH HIM. ON (B)(6) 2010, THE MSS WAS ABLE TO SPEAK TO THE PATIENT AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT HIS TESTING FREQUENCY IS 3X PER DAY AFTER EACH MEAL AND MANAGES HIS DIABETES WITH INSULIN (NOVOLOG 70/30) BASE ON HIS READINGS. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6) 2010 AT AN UNSPECIFIED TIME. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "400 AND 260 MG/DL" WITH THE SUBJECT METER AND "156 AND 260 MG/DL" ON ANOTHER METER (RELION BRAND METER), PERFORMED WITHIN 30 MINUTES OF EACH OTHER; WHICH HE CONFIRMED DOES NOT MEET WITHIN HIS AVERAGE READINGS OF "156-250 MG/DL". BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF SOME OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. AS A RESULT OF THE "400 MG/DL" READING, THE PATIENT CONFIRMED THAT HE INCREASED HIS DOSE OF INSULIN TO 21 UNITS INSTEAD OF 12-15 UNITS THAT EVENING. THE PATIENT CLAIMED 6 HOURS AFTER THE ALLEGED ISSUE OCCURRED, HE WOKE UP FEELING NAUSEAS AND SWEATY; WHICH HE ASSOCIATED AS LOW BLOOD SUGAR SYMPTOMS. IN RESPONSE TO THE SYMPTOMS, THE PATIENT CORRECTED AND CONFIRMED HE ATE SOMETHING SWEET AND ½ HOUR LATER HE FELT BETTER. THE PATIENT CLAIMED HE WAS ABLE TO TEST ON HIS RELION METER BUT HE COULD NOT RECALL THE RESULT OBTAINED. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE RESULTS FROM THE SUBJECT METER AND THAT THE CORRECT UNIT OF MEASURE WAS SET CORRECTLY. THE PATIENT DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE HE REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3020077

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R