BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1022509 · Received March 31, 2008

    Report

    Report Number
    1823260-2008-02862
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 1, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER REPORTS BACK TO BACK TESTING ON METER TO LAB WHILE USING THE INFORM SYSTEM WITH RESULTS OF 124 MG/DL ON THE METER AND 18 MG/DL AT THE LAB. L1 AND L2 QUALITY CONTROLS WERE RUN THE SAME DAY AND WERE IN RANGE. PATIENT WAS GIVEN 1 AMPULE OF D50 AND NARCAN AN HOUR AND 9 MINUTES LATER WHEN LAB RESULT CAME BACK. PATIENT WAS EXPERIENCING ALTERED MENTAL STATUS AND SEIZURE LIKE ACTIVITY AT THE TIME OF METER TESTING, WAS ADMINISTERED ATIVAN BECAUSE THEY DID NOT BELIEVE SYMPTOMS WERE DUE TO LOW BLOOD GLUCOSE. REPORTER STATES THEY ARE UNABLE TO RETURN STRIPS: A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550528

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention DILAUDID 4MG IM EVERY 4 HRS - AS NEEDED| HALDOL 5MG IM EVERY 4 HRS - AS NEEDED| ATENOLOL 25 MG/DAY| ATIVAN 2MG EVERY 4 HRS - AS NEEDED| PHENERGAN 12.5MG IM EVERY 8 HRS - AS NEEDED| DILAUDID 4MG IV EVERY 4 HRS - AS NEEDED| TYLENOL TAB 650MG EVERY 4 HRS - AS NEEDED| CLONIDINE WKLY PATCH| PHENERGAN 12.5MG EVERY 8 HRS - AS NEEDED| NARCAN 0.2MG IV - AS NEEDED| EMLA CREAM 2.5-2.5% WITH - DIALYSIS| DILAUDID 2MG EVERY 8 HRS - AS NEEDED| BENADRYL 25MG IM EVERY 4 HRS - AS NEEDED| TYLENOL SUPP 650MG EVERY 4 HRS - AS NEEDED| FLOMAX 0.4 MG/DAY| PROTONIX 40MG/DAY| LANTUS 30 UNITS/DAY| ASPART INSULIN 6 UNITS 3X/DAY| ASPART INSULIN SLIDING SCALE - EVERY 4 HRS| HEPARIN| PROCRIT 10000 UNITS IV WITH - DIALYSIS