BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7473168 · Received April 30, 2018

    Report

    Report Number
    1823260-2018-01307
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Date of Event
    April 16, 2018
    Report Date
    May 11, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS SUBMITTED DUE TO A MISSING FOLLOW-UP NUMBER AND TO CORRECT THE NUMBERING. THIS REPORT IS A DUPLICATE OF 1823260-2018-01307-02 ALREADY SUBMITTED. THE RETURNED METER AND STRIPS OF LOT 25032112 WERE TESTED IN COMPARISON TO A RETENTION METER AND MASTER LOT STRIPS. HUMAN BLOOD SAMPLES FROM WARFARIN DONORS WERE USED. DONOR 1 INR: 2.6 INR. DONOR 2 INR: 2.8 INR. DONOR 1 HCT: 42%. DONOR 2 HCT: 60%. TESTING RESULTS: DONOR 1: RETENTION METER WITH MASTER LOT STRIPS: 2.6 INR. CUSTOMER METER WITH CUSTOMER STRIPS: 2.6 INR. DONOR 2: RETENTION METER WITH MASTER LOT STRIPS: 2.8 INR. CUSTOMER METER WITH CUSTOMER STRIPS: 2.9 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED AND THE RETENTION MATERIAL MEET THE SPECIFICATIONS. NO INFORMATION WAS PROVIDED IN THE COMPLAINT CASE THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY. THE ALLEGED RESULT OF 7.1 INR ON 16-APR-2018 AT 9:45 AM WAS NOT FOUND IN THE METER MEMORY.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)# (B)(4).

    Description of Event or Problem · 1

    A NURSE COMPLAINED THAT THEY RECEIVED QUESTIONABLE INR RESULTS FOR 1 PATIENT TESTED FROM A COAGUCHEK XS METER WITH A SERIAL NUMBER (B)(4). AT 9:45 AM THE NURSE GOT A PATIENT RESULT OF 7.1 INR. AT 9:49 AM THE NURSE GOT A PATIENT RESULT OF 4.3 INR USING A DIFFERENT FINGER. AT 9:55 AM THE NURSE GOT A PATIENT RESULT OF 3.6 INR USING A DIFFERENT FINGER. AT 9:56 AM THE NURSE GOT A PATIENT RESULT OF 2.4 INR USING A FINGER THAT HAD ALREADY BEEN STUCK. FOR THE RESULTS OF 7.1 INR AND 4.3 INR, STRIP LOT 23547713 WAS USED AND IS COVERED IN THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4). FOR THE RESULTS OF 3.6 INR AND 2.4 INR, STRIP LOT 25032112 WAS USED AND IS COVERED IN THIS MEDWATCH. THE PATIENT'S THERAPEUTIC RANGE IS 1.8 - 2.2 INR. THE NURSE BELIEVED THE RESULT OF 3.6 INR TO BE CORRECT. BASED ON THE 3.6 INR RESULT THE PATIENT'S PHYSICIAN DECIDED TO HAVE THE PATIENT'S WARFARIN DOSE HELD FOR ONE DAY. THE PATIENT DID NOT RECEIVE ANY TREATMENT BASED ON THE RESULTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER DOES NOT HAVE ANTIPHOSPHOLIPID ANTIBODIES, NO HEMATOCRIT CONCERNS , NO HEPARIN, AND NOT USING ANY DIRECT THROMBIN INHIBITORS. THERE WERE NO NEW MEDICATIONS, NO DIETARY CHANGES, NO ILLNESS REPORTED, AND NO ABNORMAL BLEEDING OR BRUISING. THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT. RELEVANT RETENTION TEST STRIPS (LOT 250321) WERE TESTED IN COMPARISON WITH THE MASTER LOT COAGUCHEK XS PT. FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315186 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032112

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male DILTIAZEM| LEVODOPA/CARBIDOPA| MIRAPEX| SYNTHROID| WARFARIN