BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERICHEK TOTAL CHLORINE REAGENT STRIP

    MDR report key: 284977 · Received July 7, 2000

    Report

    Report Number
    1833407-2000-00001
    Event Type
    Other
    Date Received
    July 7, 2000
    Date of Event
    June 22, 2000
    Report Date
    July 7, 2000
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS
    Product Code
    DJW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A TEST STRIP FOR MEASURING LOW CHLORINE LEVELS IN WATER USED TO PREPARE SOLUTIONS FOR KIDNEY DIALYSIS GAVE FALSELY LOW VALUES IN THE PRESENCE OF VERY HIGH LEVELS OF CHLORINE. THE TESTED WATER CAME FROM A HOLDING TANK THAT HAD BEEN SANITIZED WITH CHLORINE THE NIGHT BEFORE. ON JUNE 27, 2000, A VOICE MAIL REFERRED TO A "PROBLEM" WITH THE NEW REAGENT STRIP FOR LOW RANGE CHLORINE. ON JUNE 28, CO LEARNED THAT TWO PERSONS UNDERGOING KIDNEY DIALYSIS BECAME ILL BECAUSE THE WATER USED TO MAKE THE DIALYSIS SOLUTION CONTAINED CHLORINE. THE DIALYSIS CENTER PERSONNEL CHECKED THE SOLUTION WITH A TEST STRIP DESIGNED TO MEASURE HIGHER LEVELS OF CHLORINE AND SHOWED THAT THERE WAS CHLORINE PRESENT IN THE SOLUTION. THERE WAS INTERVENTION BY DIALYSIS CENTER PERSONNEL AND THE PTS HAVE NOT SUFFERED PERMANENT INJURY. THEY ARE DESCRIBED AS FINE. THE ABOVE INFO IS BASED ON TELEPHONE CONVERSATIONS. THE DIALYSIS CENTER HAS NOT YET PROVIDED A WRITTEN REPORT TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERICHEK TOTAL CHLORINE REAGENT STRIP REAGENT STRIP FOR WATER TESTING DJW ENVIRONMENTAL TEST SYSTEMS * 003040

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other