BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1894566 · Received November 9, 2010

    Report

    Report Number
    2939301-2010-09771
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/08/2010. 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 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. WEIGHT: (B)(6). 510(K) # IS K053529.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT- 1/05/2011: 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 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 IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA 2 METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6) 2010 AT 4:15 PM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 236 MG/DL ON THE REPORTED METER. THE PATIENT TOOK NO ACTIONS BASED ON THIS METER READING. AT 6:00 PM, THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING AND SWEATING. A PHYSICIAN WAS CONTACTED, AND AT 6:30 PM, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS TESTED TO BE 150 MG/DL USING THE HCP METER. THE PHYSICIAN TREATED THE PATIENT WITH GLUCOSE. THE PATIENT MANAGES HER DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER OBTAINING AN ELEVATED READING ON THE REPORTED METER, AND RECEIVED TREATMENT WITH GLUCOSE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF AN EVA BAG WITH A LEAK NEAR THE TRANSFERENCE LINES. PATIENT INJURY AND MEDICAL INTERVENTION WERE NOT REPORTED FOR THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 245 MG/DL (COMPACT PLUS GP) AND 114 MG/DL (COMPACT PLUS GF) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE; HOWEVER, STRIPS HAVE BEEN USED. REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3028675

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R