BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 3030149 · Received April 2, 2013

    Report

    Report Number
    1823260-2013-01964
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO FURTHER DATA WAS PROVIDED BY THE CUSTOMER, THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. IT WAS DETERMINED THAT THE CHIP IN THE DILUENT SYRINGE AND THE NOTED HIGH INTERNAL STANDARD VALUES ON CALIBRATIONS COULD HAVE IMPACTED THE RESULTS. A PRE-ANALYTICAL ISSUE WAS UNLIKELY SINCE THE SAMPLES WERE PROCESSED BY THE MODULAR PRE- ANALYTICS. THE ACTIONS OF THE SERVICE VISIT RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ION SELECTIVE ELECTRODE (ISE) SODIUM (NA), ISE POTASSIUM (K)AND ISE CHLORIDE (CL). THE CUSTOMER PROVIDED DATA FOR (B)(4) PATIENTS. OF THOSE 31, 25 WERE FOUND TO HAVE BEEN ERRONEOUS AND WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DEEMED THE REPEAT RESULTS TO BE THE CORRECT RESULTS. ALL RESULTS ARE IN MMOL/L. PATIENT (B)(6) HAD AN INITIAL NA OF 153, AND THE REPEAT NA RESULT WAS 141. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 152, AND THE REPEAT NA RESULT WAS 143. A PREVIOUS RESULT OF 142 WAS ALSO PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 143, AND THE REPEAT NA RESULT WAS 134. A PREVIOUS RESULT OF 139 WAS PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 147, AND THE REPEAT NA RESULT WAS 137. TWO PREVIOUS RESULTS OF 131 AND 137 WERE PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 142, AND THE REPEAT NA RESULT WAS 133. A PREVIOUS RESULT OF 135 WAS PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 150, AND THE REPEAT NA RESULT WAS 138. A PREVIOUS RESULT OF 143 WAS PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 141, AND THE REPEAT NA RESULT WAS 133. TWO PREVIOUS RESULTS OF 130 AND 136 WERE PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 145, AND THE REPEAT NA RESULTS WERE 121 AND 156. PREVIOUS NA RESULTS OF EITHER 146 OR 148, AND 135 WERE PROVIDED. THE PATIENT HAD AN INITIAL K RESULT OF 4.7, AND THE REPEAT K RESULTS WERE 3.98 AND 5.20. ADDITIONAL K RESULTS OF 4.7 AND 4.5 WERE PROVIDED. THE PATIENT ALSO HAD AN INITIAL CL RESULT OF 106, AND THE REPEAT CL RESULTS WERE 86 AND 114. ADDITIONAL CL RESULTS OF 99 AND 105 WERE ALSO PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 146, AND THE REPEAT NA RESULT WAS 137. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 150, AND THE REPEAT NA RESULT WAS 112 AND 140. TWO PREVIOUS NA RESULTS OF 151 AND 147 WERE PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 147, AND THE REPEAT NA RESULT WAS 139. A PREVIOUS RESULT OF 138 WAS PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 154, AND THE REPEAT NA RESULT WAS 143. A PREVIOUS RESULT OF 141 WAS PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 139, AND THE REPEAT NA RESULT WAS 133. A PREVIOUS RESULT OF 135 WAS PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 147, AND THE REPEAT NA RESULT WAS 135. THE PATIENT ALSO HAD AN INITIAL CL RESULT OF EITHER 109 OR 104, THE CUSTOMER WAS UNABLE TO CLARIFY. THE REPEAT RESULT WAS 97. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 152, AND THE REPEAT NA RESULT WAS 141. A PREVIOUS RESULT OF 144 WAS PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 146, AND THE REPEAT NA RESULT WAS 137. TWO PREVIOUS RESULTS OF 142 AND 128 WERE PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 146, AND A REPEAT NA RESULT OF 136. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 146, AND A REPEAT NA RESULT OF 138. A PREVIOUS RESULT OF 140 WAS PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF EITHER 139 OR 134, THE CUSTOMER WAS UNABLE TO CLARIFY. THE REPEAT RESULT WAS 131. PREVIOUS RESULTS OF 137 AND 133 WERE PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 146, AND THE REPEAT NA RESULT WAS 136. A PREVIOUS RESULT OF 140 WAS PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 150, AND THE REPEAT NA RESULT WAS 141. A PREVIOUS RESULT OF 140 WAS PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 153, AND THE REPEAT RESULT WAS 145. A PREVIOUS RESULT OF 145 WAS PROVIDED. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 148, AND THE REPEAT RESULT WAS 139. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 144, AND THE REPEAT RESULT WERE 128 AND 136. A PREVIOUS NA RESULT OF 139 WAS PROVIDED. THE PATIENT HAD AN INITIAL K RESULT OF 4.6, AND THE REPEAT RESULTS WERE 4.15 AND 4.46. THE PATIENT ALSO HAD AN INITIAL CL RESULT OF 104, AND THE REPEAT CL RESULTS WERE 94 AND 99. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 137, AND THE REPEAT RESULTS WERE 130 AND 131. THE PATIENT ALSO HAD AN INITIAL K RESULT OF 4.0. THE REPEAT K RESULTS WERE 4.43 AND 4.47. ONE PATIENT WAS TREATED WITH FLUIDS BASED ON THE ORIGINAL ISE RESULTS. ACCORDING TO THE CUSTOMER, THIS DID NOT LEAD TO AN ADVERSE EVENT FOR THE PATIENT. THERE WERE NO OTHER ADVERSE EVENTS. THE LOT NUMBER OF THE NA, K AND CL ELECTRODES IN USE AT THE TIME WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND A CHIP AT THE BASE OF THE DILUENT SYRINGE AT THE O-RING. HE REPLACED THE SYRINGE ASSEMBLY, AND ALSO REPLACED THE INTERNAL STANDARD REAGENT. HE PERFORMED PRECISION CHECKS. THE CUSTOMER VERIFIED THE CALIBRATIONS AND CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134779 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1