BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2134544 · Received June 20, 2011

    Report

    Report Number
    2939301-2011-04969
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 29, 2011
    Report Date
    June 9, 2011
    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

    DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS 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 K053529.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2 ((B)(6) 2011) - DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011, AND OBTAINED THE FOLLOWING INFORMATION. THE MSS WAS ADVISED THE PATIENT TESTS HIS BLOOD GLUCOSE 5X A DAY. THE PATIENT MANAGES HIS DIABETES WITH HUMALOG INSULIN (8 UNITS IN THE MORNING/ 7 UNITS AT LUNCH/ 10 UNITS AT DINNER) AND LANTUS INSULIN (15 UNITS IN THE EVENING). THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 429AM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "254, 205, 242, 226 AND 200 MG/DL" WITH THE SUBJECT METER AND "183, 117, 125 AND 180 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT STATED HIS BLOOD GLUCOSE USUALLY READS BETWEEN "110-150 MG/DL." AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT STATED HE INCREASED HIS HUMALOG INSULIN (2-3 UNITS). AFTERWARDS, THE PATIENT CLAIMED HE FELT LOW BLOOD GLUCOSE SYMPTOMS OF SHAKY, SWEATY AND WEAK. THE PATIENT DRANK ORANGE JUICE AS TREATMENT AND FELT BETTER AFTER. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3136179

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R