BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STROMATOLYSER-4DL

    MDR report key: 2380247 · Received October 20, 2011

    Report

    Report Number
    1422681-2011-00004
    Event Type
    Malfunction
    Date Received
    October 20, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 22, 2011
    Manufacturer
    SYSMEX REAGENTS AMERICA
    Product Code
    GKZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED AN UNOPENED BOX OF FFD LOT# Y1016 FROM THEIR LABORATORY. THE RETURNED CONTAINER WAS RECEIVED ON (B)(4) 2011 AND TESTED ON (B)(4) 2011 BY THE SYSMEX REAGENTS QUALITY CONTROL LABORATORY FOR PH AND OSMOLARITY. THIS REAGENT AS A RELEASE SPECIFICATION FOR PH BETWEEN 7.05 LESS THAN OR EQUAL TO PH GREATER THAN OR EQUAL TO 7.35 AND OSMOLARITY BETWEEN 67 LESS THAN OR EQUAL TO OSMOLARITY GREATER THAN OR EQUAL TO 77. THESE VALUES ARE CONFIRMED ON REPRESENTATIVE SAMPLES BEFORE A LOT IS SHIPPED. TESTING OF THE UNOPENED BOX RECEIVED FROM THE CUSTOMER YIELDED A PH VALUE OF 10.55 AND OSMOLARITY OF 77. RETAIN SAMPLES ARE HELD AT SYSMEX REAGENTS AMERICA (SRA) FOR EVERY LOT OF REAGENT MANUFACTURED. THE RETAIN SAMPLES FOR FFD LOT# Y1016 TESTED WITHIN RELEASE SPECIFICATIONS. THE MANUFACTURING OF THIS LOT WAS NOT FOUND TO BE UNIQUE COMPARED TO MANUFACTURING OF OTHER LOTS OF FFD REAGENT. ROOT CAUSE WAS NOT DETERMINED. A CUSTOMER NOTIFICATION WILL BE SENT TO ALL CUSTOMERS WHO RECEIVED THIS LOT TO ALERT THEM TO A POSSIBLE HAZARD.

    Description of Event or Problem · 1

    THE USER REPORTED TO SYSMEX ON (B)(4) 2011 THAT THEY WERE NOT RECEIVING ANY DIFFERENTIAL RESULTS WHILE USING THEIR XE-2100 HEMATOLOGY ANALYZER SERIAL NUMBER (B)(4). THE SCATTERGRAM FOR THE DIFF CHANNEL WAS APPEARING ALONG THE X-AXIS/BASELINE AND NOT WHERE THE CELLS ARE NORMALLY DISTRIBUTED. MULTIPLE TROUBLESHOOTING STEPS DETERMINED THAT THE DIFF LYSE REAGENT, STROMATOLYSER-4DL (FFD) LOT# Y1016 WAS THE ROOT CAUSE OF THE PROBLEM. WHEN THE REAGENT LOT WAS SWITCHED WITH AN ALTERNATE LOT (LOT# Y1026) THE DIFFERENTIAL SCATTERGRAM AND RESULTS RETURNED. QUALITY CONTROL VALUES RETURNED TO EXPECTED RAGES. 50 PATIENT SAMPLES WERE SUBSEQUENTLY RUN AND ALL HAD DIFFERENTIAL RESULTS AS EXPECTED. THIS MEDWATCH IS BEING GENERATED TO ADDRESS THE HIGH PH MEASURED ON THE UNOPENED BOX OF REAGENT FROM THE USER. OSHA HAZARD COMMUNICATION STANDARD, 29CFR PART 1910.1200 REQUIRES MSDS DOCUMENTATION OF INGREDIENTS WHICH HAVE BEEN DETERMINED TO BE HEALTH HAZARDS, COMPRISE 1% OR GREATER OF THE COMPOSITION, ARE PHYSICAL HAZARDS, ARE CAPABLE OF RELEASE TO EXCEED PERMISSIBLE EXPOSURE LIMIT / THRESHOLD LIMIT VALUES OR HAVE BEEN IDENTIFIED AS CARCINOGENS. STROMATOLYSER-4DL DOES NOT HAVE INGREDIENTS WITH ANY OF THOSE CHARACTERISTICS AND THEREFORE, A MATERIAL SAFETY DATA SHEET (MSDS) IS NOT REQUIRED FOR THIS PRODUCT. THE PH VALUES RECEIVED ON THE RETURN SAMPLES FROM CUSTOMERS WERE BASIC (ALKALINE). THE PH CAN BE USED TO DETERMINE IF A MATERIAL IS HAZARDOUS, GENERALLY COMBINED WITH ADDITIONAL FACTORS SUCH AS AN MSDS OR OTHER REFERENCES. OSHA REPORTS THAT A MATERIAL WITH A PH GREATER THAN OR EQUAL TO 11 TO 14 WILL CAUSE SIGNIFICANT EYE IRRITATION AND MAY CAUSE PERMANENT DAMAGE OR BLINDNESS. FOR SKIN, A PH GREATER THAN OR EQUAL TO 12 IS CONSIDERED HAZARDOUS. OSHA REQUIRES LABORATORIES SUCH AS HEMATOLOGY LABORATORIES TO HAVE MEASURES IN PLACE TO PREVENT AND LIMIT AND EMPLOYEE'S EXPOSURE TO HAZARDOUS MATERIALS. IF THIS ISSUE WERE TO RECUR, RESULTING IN REAGENT WITH AN INCREASED PH, THERE IS A POTENTIAL FOR OPERATOR INJURY TO RESULT. IN A HEMATOLOGY LABORATORY, OPERATORS ARE REQUIRED TO WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE) IN SOME CIRCUMSTANCES BECAUSE, HAZARDS ARE PRESENT. ALTHOUGH, THE STANDARD SAFETY PRECAUTIONS ARE DEFINED INT HE OPERATORS MANUAL (INSTRUCTIONS FOR USE) FOR HANDLING REAGENTS, A USER MAY NOT WEAR FULL PPE IF NO KNOWN HAZARDS ARE PRESENT; FOR EXAMPLE IF CLOSED TUBES ARE LOADED ONTO A CLOSED SYSTEM ANALYZER AND NO BLOOD WILL BE EXPOSED. CAUTIONS IN THE INSTRUCTIONS FOR USE INCLUDE: "AVOID DIRECT CONTACT WITH REAGENTS. REAGENTS CAN CAUSE IRRITATION OF THE EYES, SKIN AND MUCOUS MEMBRANES. SHOULD YOU INADVERTENTLY COME IN CONTACT WITH REAGENT, IMMEDIATELY RINSE SKIN THOROUGHLY WITH WATER. IF A REAGENT SHOULD GET IN YOUR EYES, RINSE THOROUGHLY WITH WATER AND CONTACT YOUR DOCTOR IMMEDIATELY." IT IS POSSIBLE THAT WHILE CHANGING A PRESUMED NON-HAZARDOUS REAGENT ON AN ANALYZER (IN THIS CASE FD REAGENT WITH NO MSDS), AN OPERATOR MAY NOT USE THE LEVEL OF PROTECTION THAT THEY WOULD FOR A KNOWN HAZARDOUS SUBSTANCE. WHILE THE POTENTIAL IS LOW, IN THE TIME BETWEEN OPENING THE CAP ON THE REAGENT CONTAINER AND CONNECTING THE SPOUT KIT, THERE IS A CHANCE FOR SPLASHING/SPILLING OF LIQUID. IT IS UNKNOWN WHAT LEVEL OF INJURY/DAMAGE THIS REAGENT AT THE INCREASED PH OBSERVED WOULD CAUSE IF IT CAME IN CONTACT WITH AN OPERATOR'S SKIN AND OR EYES. SYSMEX HAS NOT RECEIVED ANY REPORTS FROM THE FIELD OF OPERATOR INJURY RELATED TO ANY LOT OF STROMATOLYSER-4DL. (FFD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STROMATOLYSER-4DL DIFFERENTIAL LYSE REAGENT GKZ SYSMEX REAGENTS AMERICA Y1016

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMATOLOGY ANALYZER: XE-2100, SERIAL # (B)(4)