BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1131898 · Received August 19, 2008

    Report

    Report Number
    2939301-2008-01905
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IN 2008 AT 11:22 AM, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONETOUCH ULTRA METER HAD AN ERROR 2 MESSAGE. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CONTACT THE PT TO OBTAIN ADDITIONAL INFO. THE PT NORMALLY TESTS HER BLOOD GLUCOSE THREE TIMES A DAY AND MANAGES HER DIABETES WITH 1000 MG GLUCOPHAGE TAKEN ONCE OR TWICE DAILY DEPENDING ON HER BLOOD GLUCOSE LEVEL. AT 6:30 AM ON SIX DAYS EARLIER, THE PT REPORTEDLY WOKE UP FEELING "REALLY SWEATY AND LIGHTHEADED" AND REPORTEDLY NOTICED THE ERROR 2 MESSAGE ON THE SUBJECT METER WHEN SHE ATTEMPTED TO TEST. THE PT THEN HAD HER USUAL BREAKFAST AND TOOK HER GLUCOPHAGE BUT WAS REPORTEDLY STILL SWEATY AND LIGHTHEADED, SO SHE TRIED TESTING ON THE SUBJECT METER AGAIN BUT THE REPORTED ISSUE REPORTEDLY PERSISTS. THE PT CLAIMED THAT SHE WAS "WORRIED THAT HER BLOOD GLUCOSE WAS TOO HIGH, SO THE METER WAS UNABLE TO OBTAIN A READING", THEREFORE, SHE WENT TO A CLINIC AT 10 AM AND WAS REPORTEDLY TESTED ON THE CLINIC'S METER WITH A "137 MG/DL". THE PT CLAIMED THAT NORMALLY HER BLOOD GLUCOSE RUNS FROM 99-120 MG/DL. AFTER OBTAINING THE "137 MG/DL", THE PT WAS REPORTEDLY GIVEN ORANGE JUICE AND RESTED UNTIL HER REPORTED SYMPTOMS SUBSIDED BEFORE HEADING HOME. THIS WAS NOT A NEW OUT OF BOX PRODUCT. THE CONDITION OF THE TEST STRIPS WERE GOOD AND TESTING TECHNIQUE WAS CORRECT; HOWEVER, THE PT DID NOT HAVE A NEW VIAL OF TEST STRIPS TO RETEST THE METER WITH. THE ISSUE WAS STILL UNRESOLVED WHEN A RETEST WAS PERFORMED. THE PATIENT'S PRODUCTS HAVE BEEN REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: ALTHOUGH THE PT WAS REPORTEDLY SWEATY AND LIGHTHEADED BEFORE TESTING, IT REPORTEDLY DID NOT GO AWAY UNTIL AFTER SHE WAS TREATED WITH ORANGE JUICE AT A HEALTHCARE PROFESSIONAL'S OFFICE FOR POSSIBLE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2831328

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening| R