BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7308871 · Received March 2, 2018

    Report

    Report Number
    1823260-2018-00625
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 12, 2018
    Report Date
    March 8, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    ONE VIAL OF TEST STRIP LOT 244034-11 CONTAINING 1 TEST STRIPS AND THE COAGUCHEK INRANGE WERE RECEIVED FOR INVESTIGATION. THE TEST STRIP AND VIAL SHOWED NO DEFECTS. THE METER APPEARED UNDAMAGED AND WAS CLEAN ON THE OUTSIDE. THE RETURNED TEST STRIP WAS MEASURED WITH THE RETURNED METER IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP . FOR THIS PURPOSE, ONE HUMAN BLOOD SAMPLE FROM A MARCUMAR DONOR AND INTERNAL REFERENCE METERS WERE USED. MASTER LOT AND RETENTION METER. MARCUMAR 3: 1.6 INR. CUSTOMER STRIPS AND CUSTOMER METER. MARCUMAR 3: 1.6 INR. THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WITH THE SAME BLOOD SAMPLE WAS 0.0 INR. THE RETURNED CUSTOMER MATERIAL AND RETENTION MATERIAL COMPLIED WITH SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT TESTED WITH COAGUCHEK INRANGE SERIAL NUMBER (B)(4). AT 12:07 P.M., A CAPILLARY SAMPLE FROM THE PATIENT WAS TESTED ON THE METER, RESULTING AS 7.7 INR. AT 12:10 P.M., A CAPILLARY SAMPLE FROM THE PATIENT WAS TESTED ON THE METER, RESULTING AS 4.6 INR. UPON REVIEW OF THE METER MEMORY, THE PATIENT HAD AN ADDITIONAL METER RESULT OF 4.4 INR AT 13:57. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE PATIENT'S THERAPEUTIC RANGE IS AROUND 3.5 INR. THE CUSTOMER'S PRODUCT WAS REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 244034) WERE TESTED IN COMPARISON WITH THE MASTER LOT TEST STRIPS. FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE WITHIN SPECIFICATIONS. UPON REVIEW OF THE METER MEMORY, THE FOLLOWING ADDITIONAL ERRONEOUS VALUE WERE OBSERVED: ON (B)(6) 2018 AT 11:58, THE PATIENT HAD A RESULT OF 5.2 INR. ON (B)(6) 2018 AT 12:08, THE PATIENT HAD A RESULT OF 4.3 INR. ON (B)(6) 2018 AT 18:19, THE PATIENT HAD A RESULT OF 1.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151996 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 244034-11

    Patients

    Seq Age Sex Outcome Treatment
    1 33 MO ARTIFICIAL HEART VALVE| ENALAPRIL (1-0-1, IN EVENING)| LASIX (1-0-0)| LENNOXIN (1-0-0)| MARCUMAR| METROPROLOL (1-1-1)| SPIRONOLAKTON (0-1-0)