BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1834187 · Received September 14, 2010

    Report

    Report Number
    1823260-2010-05446
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    September 8, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE FIRST COAGUCHEK XS SUSPECT DEVICE USED. (B)(4).

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 3.7 INR ON TWO DIFFERENT COAGUCHEK XS SYSTEMS AND 2.7 INR ON A COMPARISON LAB. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. CALLER REPORTS THAT THE PATIENT IS NONCOMPLIANT WITH HER MEDICATIONS AND IS ON 8000 UNITS OF HEPARIN SUB Q DAILY. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, "EXCESSIVE BLEEDING" WAS ENCOUNTERED AFTER THE PHYSICIAN PULLED THE MESH LEG THROUGH THE PATIENT'S RIGHT SACROSPINOUS LIGAMENT. IT IS UNKNOWN WHAT INTERVENTION, IF ANY, WAS PERFORMED BY THE PHYSICIAN TO STOP THE BLEEDING, BUT THE PATIENT REPORTEDLY SUFFERED NO COMPLICATIONS AND IS "FINE" POST-PROCEDURE. THE PROCEDURE WAS REPORTEDLY NOT COMPLETED DUE TO THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS 20180931

    Patients

    Seq Age Sex Outcome Treatment
    1 040 YR ALDACTONE| HEPARIN (DAILY)| AMBIEN CR| DIGOXIN| DILTIAZEM| SIMVASTATIN| SYNTHROID| COUMADIN