BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1872688 · Received October 18, 2010

    Report

    Report Number
    2939301-2010-09149
    Event Type
    Injury
    Date Received
    October 18, 2010
    Report Date
    September 30, 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

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT- 11/19/2010: 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. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    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.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH® ULTRA METER IS GIVING INACCURATE HIGH READING OF "239 MG/DL" COMPARED TO "208 MG/DL" OBTAINED ON ANOTHER METER. THE PATIENT MANAGES HER DIABETES WITH SELF ADJUSTING INSULIN. THE INACCURATE ISSUE BEGAN APPROXIMATELY 3 WEEKS PRIOR TO CONTACTING LIFESCAN. ON (B)(6) 2010, THE PATIENT REPORTEDLY INCREASED HIS DOSE OF INSULIN AS A RESULT OF THE ELEVATED READINGS. SOMETIME AFTER, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "SHAKY AND WEAK." THE PATIENT DID NOT SEEK ANY MEDICAL TREATMENT. IT WOULD HAVE BEEN HELPFUL TO HAVE MORE DETAILS CONCERNING THE PATIENT'S DIABETES REGIMEN AND THE CIRCUMSTANCES SURROUNDING THE INCIDENT. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE REPORTED METER READINGS WERE PERFORMED WITHIN 30 MINUTES. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA AFTER SHE INCREASED HER INSULIN BASED ON THE LFS METER READINGS.

    Description of Event or Problem · 1

    PT SELF TESTER REPORTS DISCREPANT RESULTS WITH METER COMPARED TO LAB. DATE: UNK, INRATIO: 7.X, LAB: 5.X (UNCERTAIN OF DECIMAL VALUES). DATE: (B)(6) 2010, INRATIO: 3.1, LAB: 2.5. TEN-FIFTEEN MINS BETWEEN RESULTS. PT'S TARGET THERAPEUTIC RANGE IS 2.0-3.0.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING REPRODUCIBLE TROPONIN (ACCUTNI) RESULTS, ABOVE THE AMI CUT OFF, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR THREE SAMPLES FROM ONE PATIENT. THE RESULTS WERE REPORTED OUT OF THE LAB. TESTING ON AN ALTERNATE METHOD RESULTED WITHIN THE NORMAL REFERENCE RANGE. THE PATIENT WAS TRANSFERRED TO THE CARDIAC UNIT DUE TO THE ELEVATED ACCUTNI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3022332

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening