BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2010084 · Received March 8, 2011

    Report

    Report Number
    1823260-2011-01211
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    January 27, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER AND EXPIRATION DATE UNKNOWN). REFERENCE MEDWATCH REPORT WITH (B)(4) PATIENT IDENTIFIER (B)(4) FOR THE SUSPECT DEVICE USED IN THE ADVANTAGE SYSTEM. REFERENCE MEDWATCH REPORT WITH (B)(4) PATIENT IDENTIFIER (B)(4) FOR THE SUSPECT DEVICE USED IN SYSTEM 2. REFERENCE MEDWATCH REPORT WITH (B)(4) PATIENT IDENTIFIER (B)(4) FOR THE SUSPECT DEVICE USED IN SYSTEM 3. OTHER: WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER STATES PATIENT WAS COMATOSE WHEN ADMITTED TO THE HOSPITAL AFTER TESTING 533 MG/DL ON A PARAMEDIC'S UNSPECIFIED ADVANTAGE SYSTEM. CALLER STATES PATIENT TESTED 144 MG/DL ON INFORM SYSTEM 1 AT 04:06 AND HI (GREATER THEN 600 MG/DL) AT 04:10 ON INFORM SYSTEM 2. COMFORT CURVE TEST STRIPS WERE USED. CALLER DID NOT KNOW HOW MUCH TIME ELAPSED BETWEEN ADVANTAGE SYSTEM RESULT AND INFORM SYSTEM RESULTS. AT 04:46 A LAB VALUE RETURNED AS 25 MG/DL. PATIENT RECEIVED THE FOLLOWING RESULTS: 147 MG/DL ON INFORM SYSTEM 2 (05:20), 106 MG/DL ON INFORM SYSTEM 1 (05:22), AND 267 MG/DL ON INFORM SYSTEM 3 (05:32). AT 05:35 A LAB VALUE RETURNED AS 34 MG/DL. PATIENT TESTED 42 MG/DL ON INFORM SYSTEM 1 (05:37) AND WAS TREATED WITH "D50" AT 05:38; PATIENT THEN TESTED 366 MG/DL ON INFORM SYSTEM 3 AT 05:39. LOW BLOOD GLUCOSE SYMPTOMS IMPROVED AFTER MEDICAL TREATMENT WAS RECEIVED. THE PATIENT WAS RELEASED FROM THE HOSPITAL 2.5 HOURS LATER. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER, CALLER NO LONGER HAS THE TEST STRIPS; 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 ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR Required Intervention "URELBUTIN"| BYSTOLIC| HUMULIN R| CARDIZEM| AMLODIPINE| HUMULIN "NPH"