BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2962208 · Received February 14, 2013

    Report

    Report Number
    3008382007-2013-03017
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 31, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT APPROXIMATELY 7PM. SHE TESTED ON THE SUBJECT METER AND OBSERVED A VALUE OF "197 MG/DL" WHICH SHE FELT WAS HIGHER THAN HER USUAL READINGS. THE PATIENT ADVISED THE MSS THAT HER NORMAL BLOOD GLUCOSE READINGS ARE LESS THAN "160MG/DL." THE PATIENT REPORTED THAT SHE TESTS 2X PER DAY, ONCE IN THE MORNING AND ONCE AT SUPPERTIME AND MANAGES HER DIABETES WITH GLIPIZIDE PILLS, ONE IN THE MORNING AND TWO AT NIGHT. SHE ADVISED THAT SHE TOOK HER USUAL DOSE OF TWO PILLS AFTER TESTING, SHORTLY AFTER 7PM. THE PATIENT CLAIMED THAT THE NEXT MORNING, AT APPROXIMATELY 7-7:30AM SHE WAS UNRESPONSIVE AND HAD PASSED OUT. HER FRIEND FOUND HER AND CONTACTED EMERGENCY MEDICAL SERVICES, (EMS) WHEN THEY ARRIVED AT APPROXIMATELY 7:30AM SHE WAS TESTED ON THE EMS'S METER AND A READING OF "35MG/DL" WAS OBSERVED. THE PATIENT CLAIMED SHE WAS TREATED WITH A GLUCAGON SHOT AND THEN WAS GIVEN GLUCOSE SOLUTION OR GEL ONCE SHE BECAME A LITTLE RESPONSIVE. THE PATIENT BECAME RESPONSIVE APPROXIMATELY 30 MINUTES LATER AND FOOD WAS THEN ADMINISTERED. THE PATIENT WAS NOT TAKEN TO THE HOSPITAL. THE PATIENT REPORTED THAT LATER THAT SAME DAY SHE WENT TO SEE HER DOCTOR AND TOOK HER METER WITH HER. SHE TESTED ON THE SUBJECT METER AND OBSERVED A VALUE OF "187MG/DL" AND WITHIN 30 MINUTES THE NURSE TOOK HER BLOOD GLUCOSE USING AN UNKNOWN BRAND HCP METER AND OBSERVED A VALUE OF "135MG/DL." BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. NO ADDITIONAL MEDICAL INTERVENTION TOOK PLACE AT THIS TIME.AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE METER WAS NOT SET TO THE CORRECT CODE NUMBER TO MATCH THE TEST STRIPS. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED HER NORMAL 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
    64724 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3325763

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R