BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1912022 · Received December 1, 2010

    Report

    Report Number
    2939301-2010-10391
    Event Type
    Injury
    Date Received
    December 1, 2010
    Report Date
    November 10, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/23/2010. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBER INTERBODY FUSION AT L2-L5. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING FINAL TIGHTENING OF THE SETSCREW ON THE CROSSLINK. THE BROKEN PIECE WAS RECOVERED. NO PATIENT COMPLICATIONS WERE REPORTED.

    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 HIS SECONDARY METER ONETOUCH ULTRA. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/ PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN A MONTH OR MORE PRIOR TO CONTACTING LFS. ON AN UNSPECIFIED DATE/TIME THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "196 AND 212 MG/DL" WITH THE SUBJECT METER AND "160 MG/DL" THE ONETOUCH ULTRA 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. ALONG WITH DIET AND EXERCISE, THE PATIENT STATED HE ALSO MANAGES HIS DIABETES WITH A SINGLE PILL OF JANUMET; HOWEVER, IT IS NOT KNOWN HOW OFTEN THE PATIENT TESTS HIS BLOOD GLUCOSE AND HOW OFTEN THE PATIENT TAKES HIS DIABETES ORAL MEDICATION. IN RESPONSE TO THE ALLEGED ISSUE THE PATIENT INDICATED HE ADMINISTERED 1 ½ PILLS ON AN UNSPECIFIED DATE IN (B)(6) 2010. HOWEVER, IT IS NOT KNOWN IF THE PATIENT WAS ADVISED BY HIS PHYSICIAN TO INCREASE HIS MEDICATION AND IT IS NOT KNOWN IF THE PATIENT CONTINUED TO TAKE THE ADDITIONAL ½ A PILL ON A REGULAR BASIS. A WEEK AFTER THE ALLEGED ISSUE OCCURRED (DATE/TIME NOT SPECIFIED), THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS OF BLURRY VISION, DIZZINESS, AND SHAKING. IT IS NOT KNOWN IF THE PATIENT TESTED WITH THE SUBJECT METER AT THE ONSET OF HIS SYMPTOMS, THE DURATION OF THE PATIENT'S SYMPTOMS IS NOT SPECIFIED, AND IT IS UNCLEAR IF AND HOW THE PATIENT TREATED HIS SYMPTOMS. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, HE WAS CLEANING THE PUNCTURE AREA PROPERLY, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING (MG/DL), AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S BOOKLET) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH 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. 3033330

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening