BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 17888925 · Received October 6, 2023

    Report

    Report Number
    1823260-2023-03220
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    August 27, 2023
    Report Date
    October 27, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    00365702127104
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B7 WAS UPDATED. THE METER AND TEST STRIPS WERE PROVIDED FOR INVESTIGATION WHERE THEY WERE TESTED USING RETENTION CONTROLS. SECTION D9 WAS UPDATED. TESTING RESULTS (QC RANGE = 2.5 ¿ 3.5 INR): QC 1: 3.0 INR QC 2: 3.0 INR QC 3: 3.0 INR THE OBTAINED QC VALUES WERE IN THE ALLOWED RANGE OF THE USED COMBINATION STRIP LOT - QC LOT. ALL MEASUREMENTS WERE WITHOUT ERROR MESSAGES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    SECTION E3: OCCUPATION IS THE PATIENT'S DAUGHTER. THE MEDICAL OPINION BY A ROCHE PHYSICIAN CONCLUDED THAT THE INFORMATION PROVIDED DOES NOT REASONABLY SUGGEST THE DEVICE CONTRIBUTED TO THE PATIENT'S HOSPITALIZATION FOR TIA OR STROKE. THE PATIENT¿S INR PRIOR TO BOTH THE TIA AND THE STROKE WERE THERAPEUTIC AND NO DOSING CHANGES WERE MADE PRIOR TO THE EVENT. FURTHERMORE, THERE IS A SIGNIFICANTLY INCREASED SHORT TERM RISK OF AN ISCHEMIC STROKE AFTER A TIA WITH AN INCIDENCE OF 2 TO 17% (HILL MD, COUTTS SB. PREVENTING STROKE AFTER TRANSIENT ISCHEMIC ATTACK. CMAJ. 2011;183(10):1127-1128. DOI:10.1503/CMAJ.110704). ON (B)(6) 2023 HIS INR AT THE HOSPITAL WAS 5.4 WHILE IT WAS 3.4 ON HIS METER PRIOR TO GOING TO THE HOSPITAL. THE DAUGHTER DID NOT KNOW WHETHER THIS WAS WITHIN 4 HOURS. ALTHOUGH THE RESULTS MAY BE DISCREPANT, THE DAUGHTER DID STATE THAT WHEN THE PATIENT WAS FOUND TO BE CONFUSED, HE WAS TAKING TOO MUCH WARFARIN. THIS MAY HAVE CONTRIBUTED TO HIS HIGHER INR AT THE HOSPITAL. THIS IS SUBSTANTIATED, AS HIS INR CONTINUED TO RISE AT THE HOSPITAL REQUIRING THE PATIENT TO RECEIVE VITAMIN K THE NEXT DAY. FURTHERMORE, THIS POSSIBLE DISCREPANCY DID NOT SIGNIFICANTLY IMPACT THE PATIENT¿S CLINICAL COURSE AS THE PATIENT WAS ACTUALLY SUPRATHERAPEUTIC WHICH WOULD NOT PLACE HIM AT INCREASED RISK OF AN ISCHEMIC/EMBOLIC STROKE. THE COAGUCHEK XS METER SERIAL NUMBER WAS (B)(6). THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ON A REGULAR BASIS, COAGUCHEK STRIPS OF LOTS CURRENTLY VALID IN THE MARKET ARE TESTED AS PART OF ROUTINE RETENTION TESTING AND RESULTS HAVE PASSED THE INTERNAL INSPECTION. PER PRODUCT LABELING, "COAGUCHEK USES HUMAN RECOMBINANT THROMBOPLASTIN. THEREFORE, THE COMPARABILITY TO OTHER HUMAN RECOMBINANT THROMBOPLASTINS IS BEST, WHEREAS HIGHER DEVIATIONS CAN OCCUR WITH OTHER THROMBOPLASTINS. HOWEVER, THOSE HIGHER DIFFERENCES BETWEEN THROMBOPLASTINS OF DIFFERENT (RABBIT, BOVINE BASED) ORIGIN ARE NOT A COAGUCHEK SPECIFIC ISSUE. SIMILAR DIFFERENCES CAN BE OBSERVED WHEN A HUMAN RECOMBINANT THROMBOPLASTIN-BASED LABORATORY METHOD IS COMPARED AGAINST SEVERAL OTHER (RABBIT, BOVINE-BASED) LABORATORY METHODS."

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS WITH A COAGUCHEK XS METER COMPARED TO AN UNKNOWN LABORATORY METHOD. ON (B)(6) 2023 THE RESULT FROM THE METER WAS REPORTEDLY 3.4 INR. ON (B)(6) 2023 THE RESULT AN UNKNOWN TIME LATER FROM AN UNKNOWN LABORATORY METHOD WAS REPORTEDLY 5.4 INR. THE PATIENT¿S THERAPEUTIC RANGE IS REPORTEDLY 2.5 ¿ 3.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072166 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS 65031521 00365702127104

    Patients

    Seq Age Sex Outcome Treatment
    1 Male WARFARIN