BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 388404 · Received April 12, 2002

    Report

    Report Number
    2939301-2002-05155
    Event Type
    Injury
    Date Received
    April 12, 2002
    Date of Event
    March 7, 2002
    Report Date
    March 18, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A FAMILY MEMBER CALLED TO REPORT PT HAD BEEN HOSPITALIZED. FAMILY MEMBER TOOK THE METER TO A PHARMACY WHO ADVISED PT TO CALL REGARDING THE METER. THEY DID NOT TEST THE METER. THE NIGHT OF 3/2002 DR VISITED PT AT HOME WHEN THE PT BECAME FAINT. DR'S UNKNOWN METER 452 MG/DL. THEIR OWN METER 175 MG/DL AT 8PM SAME NIGHT. TIME DIFFERENCE UNKNOWN. NO TREATMENT. IN THE MORNING A NURSE CAME TO THE HOME AT REQUEST OF SPOUSE. SPOUSE DREW VENOUS SAMPLE THAT WAS SENT TO THE LAB. RESULT 400 MG/DL. SPOUSE WAS ADVISED TO GO IMMEDIATELY TO THE HOSP BY THE "BIOLOGIST" AFTER THE RESULT WAS KNOWN. THE LAB DRAW UPON ADMIT WAS 17 MMOL/L. PT HAD BEEN VOMITING FOR TWO HOURS PRIOR TO ADMIT. THE MORE LIQUIDS PT DRANK, THE MORE PT VOMITED. AT SOME POINT PT HAD A HEART ATTACK. AS OF 4/2002 PT WAS STILL IN HOSP BEING TREATED WITH INSULIN, 2.6 UNITS MORNING AND 1.8 UNITS EVENING. PRIOR TO ADMIT PT WAS ON TWO GLUCOPHAGE MORNING AND EVENING. PT HAD NOT DISCONTINUED OR LOWERED THEIR GLUCOPHAGE WHEN AT HOME. NO ALLEGATION OF HARM WAS MADE. THE FAMILY MEMBER HAD CALLED BECAUSE OF THE COMPARISON TO THE DR'S METER AND THE LAB READING. OTHER RESULT FROM METER'S MEMORY IN THEIR UNIT OF MEASURE, MG/DL; NO MEDICATION STATUS KNOWN: 248; 222; 274; 334; 143. NO TESTS SHOWN BETWEEN DECEMBER AND MARCH. NO FURTHER INFO HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R