BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7118324 · Received December 14, 2017

    Report

    Report Number
    1823260-2017-02941
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    December 2, 2017
    Report Date
    January 10, 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 FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    TWO VIALS OF TEST STRIP LOT 244034-11 EACH VIAL CONTAINING >10 TEST STRIPS AND THE CUSTOMER'S METER WERE RECEIVED FOR INVESTIGATION. THE TEST STRIPS AND VIAL SHOWED NO DEFECTS. THE METER APPEARED UNDAMAGED AND WAS CLEAN ON THE OUTSIDE. THE RETURNED TEST STRIPS WERE MEASURED WITH THE RETURNED METER IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP. FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND INTERNAL REFERENCE METERS WERE USED. MASTER LOT /RETENTION METER: MARCUMAR 3: 2.7 INR, MARCUMAR 4: 3.7 INR. CUSTOMER STRIPS/CUSTOMER METER: MARCUMAR 3: 2.7 INR (FIRST VIAL) 2.8 INR (SECOND VIAL), MARCUMAR 4: 3.7 INR (FIRST VIAL) 3.8 INR (SECOND VIAL). THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WITH THE SAME BLOOD SAMPLE WAS 4 %. THE RETURNED CUSTOMER MATERIAL AND RETENTION MATERIAL COMPLIED WITH SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER STATED THEY RECEIVED INCORRECT RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4) FOR OVER ONE YEAR. SPECIFIC DATA WAS ONLY PROVIDED FOR AN EVENT ON (B)(6) 2017. A QUESTIONABLE RESULT WAS RECEIVED FROM THE COAGUCHEK XS METER WHEN COMPARED TO THE RESULT FROM A COAGUCHEK INRANGE METER SERIAL NUMBER (B)(4) THAT WAS ON LOAN FROM A CLINIC. THE COAGUCHEK INRANGE DEVICE IS NOT SOLD IN AND IS NOT LIKE OR SIMILAR TO A DEVICE SOLD IN THE UNITED STATES. THE TESTS WERE PERFORMED DIRECTLY AFTER EACH OTHER AND BLOOD FROM ONE FINGER WAS APPLIED TO BOTH TEST STRIPS WITH A COAGUCHEK CAPILLARY TUBE. THE RESULT FROM THE COAGUCHEK XS AT 10:39 WAS (B)(6). THE RESULT FROM THE COAGUCHEK INRANGE WAS (B)(6). THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PATIENTS THERAPEUTIC RANGE WAS 2-3 INR. THE SUSPECT METER AND STRIPS WERE REQUESTED TO BE RETURNED FOR FURTHER INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 244034-10) WERE TESTED IN COMPARISON WITH THE MASTER LOT COAGUCHEK XS PT. FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM (B)(6) DONORS AND (B)(6) INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE ACCEPTABLE AND RETENTION MATERIAL COMPLIES WITH SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897478 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 24403411

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR