BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PROFILE METER

    MDR report key: 1030147 · Received April 15, 2008

    Report

    Report Number
    2939301-2008-00571
    Event Type
    Injury
    Date Received
    April 15, 2008
    Report Date
    March 20, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    LAY USER/PATIENT

    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 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/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH PROFILE DEVICE HAD AN INCORRECT METER AVERAGE ISSUE. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE TO THE PT ON THE FOLLOWING MONTH, TO OBTAIN/VERIFY INFO. THE PT TESTS HIS BLOOD GLUCOSE 4 TIMES A DAY. HE TESTS BEFORE EACH MEAL AND AT BEDTIME. HE TAKES SLIDING-SCALE NPH INSULIN TWICE A DAY BASED ON HIS METER READINGS. HE ALSO TAKES SLIDING-SCALE HUMALOG INSULIN BASED ON HIS METER READINGS. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED ABOUT 2 YRS AGO. HE DOES NOT UTILIZE HIS METER AVERAGES TO BASE HIS INSULIN REGIMEN. ABOUT 2 MONTHS AGO, THE PT CLAIMED THAT HE SUFFERED A HYPOGLYCEMIC EPISODE AT 1 AM. HE COULD NOT RECALL WHAT HIS BLOOD GLUCOSE READING WAS THAT NIGHT BEFORE GOING TO BED. HOWEVER, THE PT MENTIONED THAT POSSIBLY HIS METER READING WAS INACCURATELY HIGH AND THAT HE TOOK TOO MUCH SLIDING-SCALE NPH AND REGULAR INSULIN. HE FURTHER ADDED THAT POSSIBLY HE DIDN'T EAT MUCH THAT DAY OR EXERCISED BEFORE GOING TO BED. AT 1 AM THAT MORNING, THE PT WOKE UP FEELING "A LITTLE SHAKY." WHEN HE TRIED TO GET OUT OF BED, HE APPARENTLY "PASSED OUT." HIS MOTHER TREATED HIM BY GIVING HIM JUICE WHICH RELIEVED HIS SYMPTOMS. WHEN HE STARTED FEELING BETTER, THE PT TESTED HIS BLOOD GLUCOSE ON THE REPORTED METER AND GOT "35 MG/DL." HE DENIED SEEKING OR RECEIVING MEDICAL TREATMENT FROM A HEALTH CARE PROVIDER. HE WAS NOT TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. THE METER WAS REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT HE POSSIBLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER OBTAINING AN INACCURATELY HIGH RESULT ON THE METER. THE PT ALLEGED THAT HE TOOK TOO MUCH INSULIN BASED ON THE METER READING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R