BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 16776867 · Received April 20, 2023

    Report

    Report Number
    1823260-2023-01338
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 28, 2023
    Report Date
    June 23, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    00365702127104
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE METER WAS RETURNED FOR INVESTIGATION. THE TEST STRIPS WERE NOT RETURNED. THE RETURNED METER WAS MEASURED WITH RETENTION TEST STRIPS (62684220) IN COMPARISON TO THE CURRENT TEST STRIP MASTER LOT. FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR 1 HCT: 43%, DONOR 2 HCT: 40% . TESTING RESULTS: DONOR #1: RETENTION METER AND MASTER LOT STRIPS: 4.0 INR, CUSTOMER METER AND RETENTION STRIPS: 3.8 INR. DONOR #2: RETENTION METER AND MASTER LOT STRIPS: 3.0 INR, CUSTOMER METER AND RETENTION STRIPS: 2.9 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED TARGET RANGES, CONFIRMING THE FUNCTIONALITY OF THE COAGUCHEK MEASURING SYSTEM. NO ERROR MESSAGES OCCURRED. THE RETURNED CUSTOMER MATERIAL AND RETENTION MATERIAL COMPLY WITH SPECIFICATIONS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    SECTION A2 WAS UPDATED. THE REPORTER STATED THE PATIENT WAS 94 YEARS OLD AT THE TIME OF THE EVENT AND WOULD BE TURNING 95 YEARS OLD ON (B)(6) 2023, HOWEVER, THE REPORTER PROVIDED THE PATIENT'S DATE OF BIRTH AS (B)(6).

    Additional Manufacturer Narrative · 0

    SECTION E3: OCCUPATION IS PATIENT/CONSUMER. THE METER WAS RECEIVED FOR INVESTIGATION. 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. FOR THE RESULTS IN %QUICK: "ALL STRIP LOTS INCLUDE THE UPDATED LABELING AND STATES: CAUTION: THE COAGUCHEK XS METER IS PRE-SET TO DISPLAY RESULTS IN THE INTERNATIONAL NORMALIZED RATIO (INR). THE METER IS ALSO CAPABLE OF DISPLAYING RESULTS IN SECONDS (DISPLAYED ON METER AS SEC) AND % QUICK (DISPLAYED ON METER AS %Q) (A MEASURING UNIT USED MAINLY BY HEALTHCARE PROFESSIONALS IN EUROPE). WHEN TESTING FOR INR, YOU MUST CONFIRM THAT THE MEASURED RESULT IS DISPLAYED IN INR PRIOR TO USING THE RESULT AND WHENEVER THE DATE AND TIME SETTINGS ARE MODIFIED. TO RESET THE MEASURING UNIT TO INR, FOLLOW THE INSTRUCTIONS IN THE TESTING A BLOOD SAMPLE SECTION OF THE COAGUCHEK XS SYSTEM USER MANUAL FOR SELF-TESTING, VERSION 8.0 AND HIGHER OR CALL THE ROCHE DIAGNOSTICS TECHNICAL SERVICE CENTER AT 1-800-428-4674 FOR ASSISTANCE, IF THE RESULT IS DISPLAYED IN %Q OR SEC. ". THE INVESTIGATION IS ONGOING. H3: NA.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF DISCREPANT %QUICK RESULTS WITH COAGUCHEK XS METER SERIAL NUMBER (B)(6). THE RESULTS WERE 38 %Q AND 31%Q. THE REPORTER ALLEGED BOTH OF THESE RESULTS WERE OBTAINED ON (B)(6) 2023. WHEN REVIEWING THE METER MEMORY, THE RESULT OF 38 %Q IS LISTED WITH A DATE OF 03-FEB-2023 AND A TIME OF 8:09 P.M. THE RESULT OF 31 %Q IS LISTED WITH A DATE OF (B)(6) 2023 AND A TIME OF 8:20 A.M. THE TIME AND DATE WERE CHECKED AND THE METER HAD THE CURRENT DATE AND TIME SET CORRECTLY. THE METER WAS RESET TO READ IN INR. THE MEMORY WAS REVIEWED AFTERWARD AND THE RESULTS WERE: 1.7 INR WITH A DATE OF (B)(6) 2023 AND TIME OF 8:09 P.M. AND 1.9 INR WITH A DATE OF (B)(6) 2023 AND A TIME OF 8:20 A.M. THE PATIENT RE-TESTED ON (B)(6) 2023 WITH A RESULT OF 1.9 INR. THE PATIENT¿S THERAPEUTIC RANGE IS 2.0 ¿ 2.1 INR. THE PATIENT TESTS EVERY 2 WEEKS OR SOMETIMES ONCE A MONTH DEPENDING ON THE INR RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155629 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 62682421 00365702127104

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Female ATORVASTATIN.| CALCIUM.| CENTRUM VITAMIN.| ESCITALOPRAM.| LOSARTAN.| METOPROLOL.| TURMERIC.| VITAMIN D.| WARFARIN.