BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2465969 · Received February 23, 2012

    Report

    Report Number
    2939301-2012-01874
    Event Type
    Injury
    Date Received
    February 23, 2012
    Date of Event
    February 6, 2012
    Report Date
    February 8, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LFS PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAD TESTING COMPLETED ON (B)(4) 2012 AND TEST STRIPS TESTING WAS COMPLETED ON (B)(4) 2012, BOTH PRODUCTS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE COMPLAINT IS NOT CONFIRMED. THE 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PATIENT/LAY-USER CONTACTED LIFESCAN (LFS) ALLEGING THAT SHE WAS EXPERIENCING AN INACCURATE HIGH AND AN INACCURATE ERRATIC ISSUE WITH HER ONE TOUCH ULTRA2 METER. THE (B)(4) SPOKE WITH THE PATIENT ON (B)(6) 2012 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON (B)(6) 2012, AT 7 PM. THE PATIENT OBTAINED A GLUCOSE RESULT OF "79 MG/DL" ON THE SUBJECT METER, WHICH SHE FELT WAS INACCURATE HIGH COMPARED TO HER FEELINGS/NORMAL VALUES. SHE STATED THAT SHE TESTS 4-6X/DAY AND MANAGES HER DIABETES WITH HUMALOG INSULIN (SELF ADJUSTER) AND LANTUS AND DUE TO THE ALLEGED ISSUE SHE INCREASED HER USUAL DOSE OF MEDICATION. INSTEAD OF TAKING HER USUAL DOSE OF 12U, AT 7 PM SHE REPORTEDLY TOOK 13U BASED ON THE ALLEGED METER RESULT. THE PATIENT CLAIMED AT 8:15 PM, AFTER THE ALLEGED ISSUE STARTED, SHE FELT WARM HER EYES BECAME GLOSSY AND ROLLED BACK, AND WAS HAVING COMMUNICATION ISSUES WHERE SHE ALSO BECAME VERBALLY UNRESPONSIVE. IN RESPONSE TO HER SYMPTOMS, SHE TESTED AGAIN WITH THE SUBJECT METER AND OBTAINED GLUCOSE RESULTS OF "113, 113 AND 52 MG/DL", DONE LESS THAN 20 MINUTES APART OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. IN RESPONSE TO HER SYMPTOMS, AT 9:20 PM EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED OUT. SHE REPORTED THAT HER BLOOD GLUCOSE WAS TESTED WITH THE EMS METER, AND A RESULT OF "LOW" WAS OBTAINED, WHICH WAS TREATED WITH IV GLUCOSE. THE PATIENT STATED AFTER THE ALLEGED EMS TREATMENT WAS ADMINISTERED, HER BLOOD GLUCOSE WAS TESTED AGAIN WITH THE EMS METER AT 10:00 PM AND NOW OBTAINED GLUCOSE RESULTS OF "90 AND 142 MG/DL". DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE CORRECT UNIT OF MEASURE SET IN THE METER, AN APPROVED SAMPLE SITE AND GOOD UNEXPIRED TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LFS PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAD TESTING COMPLETED ON (B)(6) 2012 AND TEST STRIPS TESTING WAS COMPLETED ON (B)(6) 2012, BOTH PRODUCTS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening| R