BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUCOSTIK REAGENT STRIPS

    MDR report key: 37468 · Received September 6, 1996

    Report

    Report Number
    1810909-1996-00003
    Event Type
    Other
    Date Received
    September 6, 1996
    Date of Event
    March 26, 1996
    Report Date
    August 30, 1996
    Manufacturer
    BAYER CORP. BUSINESS GROUP DIAGNOSTICS
    Product Code
    CFR
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A PT WAS IN A USUAL STATE OF HEALTH UNTIL 3/23/96. ON 3/24/96 HIS WIFE WAS NOT ABLE TO AROUSE HIM. AT THE HOSPITAL HIS TEMPERATURE WAS SLIGHTLY EVALUATED AND HIS BLOOD SUGAR WAS 1091 MG/DL. HE WAS ADMITTED TO THE HOSPITAL WITH HYPERSMOLAR SHOCK AND R/O SEPSIS. THE PT INDICATED THAT HE REDUCED THE AMOUNT OF INSULIN BASED ON THE CO METER 3 READINGS OF "LO" (LESS THAN 20 MG/DL). UPON INVESTIGATION IT WAS DISCOVERED THAT THE CUSTOMER WAS GIVEN DIFFERENT REAGENT STRIPS INSTEAD OF CORRECT REAGENT STRIPS. PRODUCT LABELING SPECIFIES THE ONLY SPECIFIED REAGENT TO BE USED WITH THE CO METER IS CO'S STRIPS. THE SCENARIO EXPERIENCED BY THE CUSTOMER HAS BEEN CONFIRMED BY THESE IN-HOUSE STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOSTIK REAGENT STRIPS TEST FOR GLUCOSE IN WHOLE BLOOD CFR BAYER CORP. BUSINESS GROUP DIAGNOSTICS 2627 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R