BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243949 · Received November 25, 2008

    Report

    Report Number
    2939301-2008-03260
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    LIFESCAN, INC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER HAD AN "ERROR 4" AND "ERROR 5" ISSUE. THE PATIENT TESTS HER BLOOD GLUCOSE 1-3 A DAY. SHE TYPICALLY TESTS BEFORE BREAKFAST AND TAKES SLIDING-SCALE LANTUS INSULIN TWICE A DAY BASED ON HER METER READINGS. SHE ALSO TAKES SLIDING-SCALE NOVOLOG INSULIN 3 TIMES A DAY BASED ON HER METER READINGS. ON THE DAY BEFORE, THE PATIENT STATED THAT SHE ATE GRAHAM CRACKER PRIOR TO GOING TO BED. THE NEXT MORNING AT 7:30 AM, THE PATIENT ATTEMPTED SEVERAL TIMES TO TEST HER BLOOD GLUCOSE BEFORE EATING BREAKFAST BUT KEPT ENCOUNTERING "ERROR 4" AND "ERROR 5" MESSAGES. ALTHOUGH THE PATIENT CLAIMED THAT SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE THAT MORNING, SHE ASSUMED THAT HER BLOOD GLUCOSE WAS PROBABLY ELEVATED DUE TO HAVING EATEN THE CRACKERS THE NIGHT BEFORE. THE PATIENT THEN DECIDED TO GUESS ON HOW MUCH LANTUS AND NOVOLOG INSULIN TO TAKE. SHE TOOK AN EXTRA COUPLE OF UNITS OF EACH INSULIN AND ATE A SMALLER THAN USUAL BREAKFAST. ABOUT 4-5 HOURS LATER, THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF SWEATING AND SLEEPINESS. THE PATIENT'S NEIGHBOR NOTICED THAT SHE WAS NOT FEELING WELL AND TREATED HER WITH A TALL GLASS OF ORANGE JUICE AND A PIECE OF CHOCOLATE. THE PATIENT FELT BETTER WITHIN 10-20 MINUTES. THE PATIENT DENIED SEEKING OR RECEIVING MEDICAL TREATMENT FROM A HEALTH CARE PROVIDER DUE TO THE ALLEGED METER ISSUE. THE PATIENT DID NOT HAVE TEST STRIPS FOR TROUBLESHOOTING. THE METER WAS REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT ARE SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. THE PATIENT ALSO MENTIONED THAT HER NEIGHBOR TREATED HER WITH GOOD AND A DRINK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R