BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1051849 · Received May 22, 2008

    Report

    Report Number
    2939301-2008-00885
    Event Type
    Injury
    Date Received
    May 22, 2008
    Report Date
    April 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER, STRIPS, AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER, STRIPS, OR CONTROL SOLUTION DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRASMART METER READ INACCURATELY HIGH. THE PT TESTS HER BLOOD GLUCOSE 4 TIMES A DAY. SHE TESTS AFTER EACH MEAL AND AT BEDTIME. THE PT TAKES SLIDING-SCALE HUMALOG INSULIN BASED ON HER METER READINGS. THE PT'S NORMAL BLOOD GLUCOSE LEVELS AFTER DINNER ARE USUALLY AROUND "200 SOMETHING" MG/DL. ON THE DAY BEFORE, AFTER DINNER AT AROUND 9:00 PM, THE PT OBTAINED 2 BLOOD GLUCOSE READINGS OF "500 SOMETHING" MG/DL AND THEN "400 SOMETHING" MG/DL. AT THE TIME OF TESTING, THE PT WAS ASYMPTOMATIC. THE PT EXPLAINED THAT WHENEVER HER BLOOD GLUCOSE IS ELEVATED, SHE TYPICALLY HAS SYMPTOMS OF FEELING SICK TO HER STOMACH. BASED ON THE METER READINGS, THE PT TOOK 13 UNITS OF SLIDING-SCALE HUMALOG INSULIN. THE PT TESTED HER BLOOD GLUCOSE BEFORE GOING TO BED THAT NIGHT AND GOT "200 MG/DL." IT IS NOT KNOWN WHAT HER USUAL PRE-BEDTIME BLOOD GLUCOSE LEVELS ARE. THE NEXT MORNING AT 4:30 AM ON ORIGINAL DATE, THE PT FELT AS THOUGH SHE WAS IN A COMA AND SAID THAT SHE WAS "ALMOST UNCONSCIOUS". THE PT'S HUSBAND TESTED HER BLOOD GLUCOSE ON A BACKUP, NON-LFS METER AND GOT A METER READING OF "28 MG/DL". THE PT'S BLOOD GLUCOSE WAS NOT TESTED ON THE REPORTED METER WHEN SHE WAS ASYMPTOMATIC. THE PT'S HUSBAND TREATED THE PT WITH A GLUCAGON INJECTION WHICH HELPED TO RELIEVE HER SYMPTOMS. THE PT DID NOT SEEK OR RECEIVED MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED ISSUE. THE PT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PT WAS OBTAINING BLOOD SAMPLES FROM HER FINGERS AND CLEANING THE PUNCTURE SITES CORRECTLY. SHE PERFORMED A CONTROL SOLUTION TEST THAT PASSED. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE REQUIRED A GLUCAGON INJECTION AFTER SHE TOOK HER INSULIN, WHICH WAS BASED ON THE READING OBTAINED ON HER METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2808571

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R