BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 2883360 · Received December 21, 2012

    Report

    Report Number
    1823260-2012-06487
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 6, 2012
    Report Date
    January 15, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. AN UNSTABLE DILUTION OF THE SAMPLE MATERIAL IN THE MIXING VESSEL MAY BE THE MOST LIKELY CAUSE AS THE PRESENCE OF AIR IN THE DILUENT SYRINGE CONFIRMS THIS. THE SIPPER SYRINGE CLOT FOUND BY THE FIELD SERVICE REPRESENTATIVE MAY HAVE IMPACTED PERFORMANCE, BUT THERE WOULD HAVE BEEN GREATER IMPACT CAUSED BY AIR IN THE DILUENT SYRINGE.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER FIRST REPORTED THAT THEY HAD AIR IN THE DILUENT SYRINGE AND DEBRIS IN THE SIPPER SYRINGE. THEY QUESTIONED FORTY SIX PATIENT SAMPLES TESTED FOR ION SELECTIVE ELECTRODE (ISE) SODIUM, POTASSIUM, AND CHLORIDE. OF THE FORTY SIX SAMPLES, NINE WERE FOUND TO HAVE ERRONEOUS RESULTS. ALL INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ALL SAMPLES WERE REPEATED ON A DIFFERENT MODULAR CORE SYSTEM, SERIAL NUMBER (B)(4). ALL REPEAT RESULTS WERE CONSIDERED CORRECT AND CORRECTED REPORTS WERE ISSUED FOR THESE. SAMPLE (B)(6) INITIALLY RESULTED AS 157 MMOL/L FOR ISE SODIUM AND 116 MMOL/L FOR ISE CHLORIDE. THE SAMPLE WAS REPEATED AND RESULTED AS 141 MMOL/L FOR ISE SODIUM AND 105 MMOL/L FOR ISE CHLORIDE. SAMPLE (B)(6) INITIALLY RESULTED AS 152 MMOL/L FOR ISE SODIUM. THE SAMPLE WAS REPEATED AND RESULTED AS 145 MMOL/L FOR ISE SODIUM. SAMPLE (B)(6) INITIALLY RESULTED AS 177 MMOL/L FOR ISE SODIUM, 7.6 MMOL/L FOR ISE POTASSIUM, AND 131 MMOL/L FOR ISE CHLORIDE. THE SAMPLE WAS REPEATED AND RESULTED AS 129 MMOL/L FOR ISE SODIUM, 5.5 MMOL/L FOR ISE POTASSIUM, AND 93 MMOL/L FOR ISE CHLORIDE. SAMPLE (B)(6) INITIALLY RESULTED AS 4.9 MMOL/L FOR ISE POTASSIUM AND 128 MMOL/L FOR CHLORIDE. THE SAMPLE WAS REPEATED AND RESULTED AS 3.6 MMOL/L FOR ISE POTASSIUM AND 91 MMOL/L FOR ISE CHLORIDE. SAMPLE (B)(6), TESTED ON (B)(6) 2012, INITIALLY RESULTED AS 165 MMOL/L FOR ISE SODIUM. THE SAMPLE WAS REPEATED AND RESULTED AS 154 MMOL/L FOR ISE SODIUM. SAMPLE (B)(6), TESTED ON (B)(6) 2012, INITIALLY RESULTED AS 125 MMOL/L FOR ISE SODIUM. THE SAMPLE WAS REPEATED AND RESULTED AS 116 MMOL/L FOR ISE SODIUM. SAMPLE (B)(6), TESTED ON (B)(6) 2012, INITIALLY RESULTED AS 164 MMOL/L FOR ISE SODIUM. THE SAMPLE WAS REPEATED AND RESULTED AS 149 MMOL/L FOR ISE SODIUM. SAMPLE (B)(6), TESTED ON (B)(6) 2012, INITIALLY RESULTED AS 157 MMOL/L FOR ISE SODIUM. THE SAMPLE WAS REPEATED AND RESULTED AS 149 MMOL/L FOR ISE SODIUM. SAMPLE (B)(6), TESTED ON (B)(6) 2012, INITIALLY RESULTED AS 153 MMOL/L FOR ISE SODIUM, 6.7 MMOL/L FOR ISE POTASSIUM, AND 114 MMOL/L FOR ISE CHLORIDE. THE SAMPLE WAS REPEATED AND RESULTED AS 136 MMOL/L FOR ISE SODIUM, 6.0 MMOL/L FOR ISE POTASSIUM, AND 101 MMOL/L FOR ISE CHLORIDE. IT IS NOT KNOWN IF ANY PATIENTS WERE ADVERSELY AFFECTED BY THE EVENT. NO ADVERSE EVENTS WERE ALLEGED. THE ISE SODIUM ELECTRODE LOT NUMBER WAS R39 WITH AN EXPIRATION DATE OF 06/30/2013. THE ISE POTASSIUM ELECTRODE LOT NUMBER WAS Y80 WITH AN EXPIRATION DATE OF 05/31/2013. THE ISE CHLORIDE ELECTRODE LOT NUMBER WAS B75 WITH AN EXPIRATION DATE OF 04/30/2013. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THERE WAS A CLOT IN THE SIPPER SYRINGE. HE CLEARED THE CLOT FROM THE SIPPER SYRINGE. HE REMOVED THE COVER FROM THE ISES, THEN CLEANED AND INSPECTED DISPENSE AND SIPPER NOZZLES. HE FLUSHED DI WATER THROUGH THE WASTE LINE TO ENSURE IT WAS FREE FLOWING. HE CHECKED THE ISE SOLUTION PICK UP LINES TO BOTTLES TO ENSURE THE FILTERS WERE CLEAR AND THE TUBES WERE SEATED CORRECTLY. HE PRIMED THE SYSTEM TWICE TO ENSURE PROPER REAGENT FLUID PICKUP. HE RAN ISE CALIBRATION AND RESULTS PASSED FOR BOTH (B)(4). THE CUSTOMER RAN QUALITY CONTROL. ALL RESULTS WERE WELL WITHIN THE CUSTOMER'S NORMAL RANGES. A PRECISION CHECK WAS PERFORMED WITH ALL RESULTS WITHIN EXPECTED RANGES. THE CUSTOMER RAN SEVERAL PATIENT SAMPLES WHICH HAD RESULTS FROM EARLIER IN THE DAY AND THE RESULTS MATCHED CLOSELY. THE SYSTEM WAS RETURNED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1