BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 11401840 · Received March 2, 2021

    Report

    Report Number
    1823260-2021-00644
    Event Type
    Injury
    Date Received
    March 2, 2021
    Date of Event
    February 1, 2018
    Report Date
    March 22, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CODE WAS UPDATED.

    Additional Manufacturer Narrative · 1

    THE PATIENT ALLEGES IN A LEGAL DOCUMENT THAT THE PATIENT "HAS BEEN SERIOUSLY AND SEVERELY INJURED, WAS RENDERED SICK, SORE, LAME AND DISABLED, EXACERBATION OF PRIOR CONDITIONS, AND SUFFERED FROM, AMONG OTHER THINGS, STROKE, INTELLECTUAL IMPAIRMENT, PHYSICAL IMPAIRMENT, AND PERMANENT DISABILITIES." MEDICAL ASSESSMENT OF THE EVENT CONCLUDED, INFORMATION NECESSARY TO DETERMINE WHETHER THE COAGUCHEK CONTRIBUTED TO THE STROKE EVENT WAS NOT PROVIDED. IF FURTHER INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED. IN GENERAL, STROKES MAY BE RELATED TO INSUFFICIENT ANTICOAGULATION AND OTHER, ANTICOAGULATION INDEPENDENT CONDITIONS. THE PATIENT GROUP WITH THE NEED FOR ANTICOAGULATION IS NOT TREATED CURATIVELY BY ANTICOAGULATION. ANTICOAGULATION ONLY REDUCES THE CONSEQUENCES AND COMPLICATIONS OF THE UNDERLYING DISEASE, BUT RISKS REMAIN. IN CASE OF INSUFFICIENT ANTICOAGULATION, SEVERAL REASONS MIGHT HAVE LED TO THIS (E.G. NOT OPTIMAL THERAPEUTIC RANGE DUE TO CO-MORBIDITIES, IRREGULARITIES OF MEDICATION INTAKE/DOSAGES, IRREGULARITIES OF LIFE-STYLE, CO-MEDICATION, CO-MORBIDITIES, ETC.). NO PRODUCT IS EXPECTED FOR RETURN. ROUTINE RETENTION TESTING IS PERFORMED. TEST STRIP RETENTION SAMPLES PASSED THE INTERNAL INSPECTION. RETENTION TESTING DATA IS REVIEWED AND APPROPRIATE ACTIONS ARE TAKEN AS NEEDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. REPORTER OCCUPATION IS LAY USER/PATIENT. UNIQUE IDENTIFIER (UDI): (B)(4).

    Description of Event or Problem · 1

    AN ALLEGATION WAS RECEIVED VIA A LEGAL LETTER RELATED TO A PATIENT HAVING A STROKE DUE TO "INCORRECT AND INACCURATE" INR RESULTS FROM A COAGUCHEK XS SYSTEM WITH AN UNSPECIFIED SERIAL NUMBER. THE PATIENT HAD A STROKE IN (B)(6) 2018. THE DATE OF EVENT IS AN APPROXIMATION AS THE ACTUAL DATE OF THE STROKE WAS NOT PROVIDED. NO SPECIFIC PATIENT INFORMATION HAS BEEN PROVIDED. THE PATIENTS THERAPEUTIC RANGE, MEDICATIONS AND MEDICAL HISTORY WERE NOT PROVIDED. NO SPECIFIC DETAILS RELATED TO THE EVENT HAVE BEEN PROVIDED. NO INR RESULTS HAVE BEEN PROVIDED. NO INFORMATION RELATED TO CHANGES IN VITAMIN K ANTAGONIST (VKA) THERAPY HAS BEEN PROVIDED. NO DIAGNOSTIC RESULTS RELATED TO THE EVENT HAVE BEEN PROVIDED. IT IS NOT KNOWN WHAT TYPE OF STROKE THE PATIENT HAD (ISCHEMIC/HEMORRHAGIC) OR THE LOCATION OF STROKE. NO INFORMATION RELATED TO HOW THE PATIENT WAS TREATED HAS BEEN PROVIDED. THIS MDR IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294433 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other