BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA ENHANCED METER

    MDR report key: 2744966 · Received September 14, 2012

    Report

    Report Number
    2939301-2012-10653
    Event Type
    Injury
    Date Received
    September 14, 2012
    Report Date
    August 21, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED ON (B)(4) 2012 AND EVALUATED BY PRODUCT ANALYSIS (PA) RESPECTIVELY ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS WERE TESTED AND BOTH PASSED ALL TESTING WITH NO FAULTS FOUND. THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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) 2012, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH VITA METER IS READING INACCURATELY HIGH COMPARED TO THE CONTOUR METER. MEDICAL SURVEILLANCE SENT FOLLOW-UP QUESTIONS; HOWEVER CUSTOMER SERVICE WAS UNSUCCESSFUL IN REACHING THE PATIENT BY PHONE. THE COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING THE PATIENT'S INITIAL CALL. THE PATIENT ALLEGED THAT THE ISSUE BEGAN FOUR TO FIVE DAYS PRIOR TO CONTACTING LFS. THE PATIENT'S TESTING FREQUENCY IS NOT KNOWN AND OTHER THAN DIABETES, IT IS NOT CLEAR IF THE PATIENT SUFFERS FROM OTHER HEALTH CONDITIONS. ON UNSPECIFIED DATES/TIMES, THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF ''233, 161, AND 156MG/DL'' WITH THE SUBJECT METER AND ''181, 130, AND 119MG/DL'' WITH THE CONTOUR METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF SOME OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH INSULIN (TYPE AND DOSAGE ARE NOT KNOWN). ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT DENIED TAKING ANY ACTION IN REGARDS TO HIS DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE, AT AN UNSPECIFIED TIME LATER THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS OF SWEATING AND FEELING HOT; HOWEVER, THE PATIENT DENIED RECEIVING ANY FORM OF TREATMENT AFTER HIS SYMPTOMS BEGAN. IT IS NOT KNOWN IF THE PATIENT'S SYMPTOMS ARE ASSOCIATED WITH HIS DIABETES AND IT IS NOT KNOWN WHEN THE PATIENT'S SYMPTOMS IMPROVED. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S BOOKLET) SAMPLE SITE. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE. 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 VITA ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3310235

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening