BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 3006701 · Received March 15, 2013

    Report

    Report Number
    1823260-2013-01476
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    February 23, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. IT WAS NOTED THE CUSTOMER WAS UTILIZING A CLOTTING TIME OF 2-5 MINUTES FOR THE SAMPLES WHICH WAS NOT IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATION. ALSO, THE CUSTOMER WAS EXCHANGING THE ELECTRODES AT 2 MONTHS AND WAS TESTING 700-900 ISE SAMPLES PER ISE UNIT/DAY. PER PRODUCT LABELING, THE ELECTRODES SHOULD BE EXCHANGED EVERY 2 MONTHS OR 9000 TESTS WHICHEVER OCCURS FIRST. THE PROVIDED CALIBRATION REPORTS SHOWED CHANGING EMF VALUES FOR STANDARD CALIBRATORS. THIS MOST LIKELY WAS CAUSED BY INCREASED CONCENTRATION OF THE CALIBRATOR MATERIAL DUE TO REPEATED USE. PRODUCT LABELING STATES THE CALIBRATOR MATERIAL SHOULD ONLY BE USED ONCE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE LOW ION SELECTIVE ELECTRODE (ISE) RESULTS FOR QC MATERIAL AND APPROXIMATELY 50 PATIENT SAMPLES. THE SAMPLES WERE REPEATED ON CORE ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULTS FOR 31 WERE DISCREPANT. ALL RESULTS ARE IN MMOL/L. FOR THE FOLLOWING PATIENT SAMPLES, THE CUSTOMER COULD NOT CONFIRM WHICH RESULT WAS THE INITIAL RESULT AND WHICH WAS THE REPEAT RESULT. PATIENT SAMPLE 1: SODIUM 130/141. PATIENT SAMPLE 2: SODIUM 132/140. PATIENT SAMPLE 3: SODIUM 133/141. PATIENT SAMPLE 4: SODIUM 133/145. PATIENT SAMPLE 5: SODIUM 131/138. PATIENT SAMPLE 6: SODIUM 134/143. PATIENT SAMPLE 7: SODIUM 143/152. PATIENT SAMPLE 8: SODIUM 128/137. PATIENT SAMPLE 9: SODIUM 131/142. PATIENT SAMPLE 10: SODIUM 131/137. FOR THE FOLLOWING PATIENT SAMPLES, THE RESULTS ARE THE INITIAL RESULT FOLLOWED BY THE REPEAT RESULT. PATIENT SAMPLE 11: SODIUM 130/139. PATIENT SAMPLE 12: SODIUM 143/152. PATIENT SAMPLE 13: SODIUM 129/138. PATIENT SAMPLE 14: SODIUM 131/142. PATIENT SAMPLE 15: SODIUM 133/140. PATIENT SAMPLE 16: SODIUM 129/136. PATIENT SAMPLE 17: SODIUM 126/136. PATIENT SAMPLE 18: SODIUM 132/141. PATIENT SAMPLE 19: SODIUM 131/140. PATIENT SAMPLE 20: SODIUM 131/137. PATIENT SAMPLE 21: SODIUM 132/140. PATIENT SAMPLE 22: SODIUM 128/137. PATIENT SAMPLE 23: SODIUM 134/142. PATIENT SAMPLE 24: SODIUM 134/155, POTASSIUM 4.7/5.5, CHLORIDE 104/120. PATIENT SAMPLE 25: SODIUM 131/138. PATIENT SAMPLE 26: SODIUM 134/143. PATIENT SAMPLE 27: SODIUM 122/129. PATIENT SAMPLE 28: SODIUM 130/141. PATIENT SAMPLE 29: SODIUM 133/145. PATIENT SAMPLE 30: SODIUM 132/140. PATIENT SAMPLE 31: SODIUM 133/141. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT AND CORRECTIVE REPORTS WERE GENERATED. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE PROBLEM COULD NOT FIND A CAUSE. THE CUSTOMER REPLACED AND PRIMED THE ISE REAGENTS AND PERFORMED CALIBRATION OF ISE 1 AND 2. THE FIELD SERVICE REPRESENTATIVE CHECKED THE ISE PROBE ADJUSTMENTS, ISE 1 AND 2 SIPPER AND VACUUM FLOW PATH AND CHECKED FOR PROPER REAGENT DISPENSE. AS AN ADDITIONAL PREVENTIVE MEASURE, HE REPLACED ISE 1 SIPPER PROBE AND CLEANED ISE 1 AND 2 SIPPER FLOW PATH. PRECISION TESTING WAS PERFORMED AND THE CUSTOMER RAN CALIBRATION AND QC WITH ALL RESULTS WERE WITHIN THEIR GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110042 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1