BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM

    MDR report key: 2247769 · Received September 14, 2011

    Report

    Report Number
    1823260-2011-04845
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Date of Event
    August 29, 2011
    Report Date
    March 14, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIC
    PMA / PMN Number
    K872306
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE THE ROOT CAUSE OF THE ISSUE. THE MAINTENANCE ACTIONS OF AN AIR PURGE AND RINSING/ PRIMING OF THE CHANNEL IN COMBINATION WITH RECALIBRATION OF THE ASSAY SOLVED THE ISSUE. INSUFFICIENT SYSTEM PERFORMANCE WAS NOT INDICATED AS NO IRREGULARITIES IN THE CALIBRATION OR QUALITY CONTROL DATA WERE NOTED. A MALFUNCTION OF THE ANALYZER WAS NOT SUPPORTED BY REVIEW OF THE ALARM TRACE. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE CALCIUM RESULTS FOR APPROXIMATELY 70 PATIENT SAMPLES FROM THE ANALYTICAL D MODULE ANALYZER SERIAL NUMBER (B)(4). THE USER STATED THEY NOTICED LOW CALCIUM RESULTS AT 4:00 PM AND STOPPED TESTING PATIENT SAMPLES. THEY PERFORMED MAINTENANCE, RECALIBRATED THE ASSAY AND RAN QUALITY CONTROL WITH ACCEPTABLE RESULTS. THE USER THEN RETESTED ALL PATIENT SAMPLES ORIGINALLY TESTED AT 4:00 PM AND LATER ON ANALYTICAL D MODULE ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED FOR 47 PATIENT SAMPLES, THE RESULTS FOR 30 WERE DISCREPANT. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 7.0 AND THE REPEAT RESULT WAS 9.0. PATIENT SAMPLE 2 INITIAL RESULT WAS 7.3 AND THE REPEAT RESULT WAS 9.2. PATIENT SAMPLE 3 INITIAL RESULT WAS 7.2 AND THE REPEAT RESULT WAS 9.5. PATIENT SAMPLE 4 INITIAL RESULT WAS 7.6 AND THE REPEAT RESULT WAS 9.8. PATIENT SAMPLE 5 INITIAL RESULT WAS 7.5 AND THE REPEAT RESULT WAS 9.9. PATIENT SAMPLE 6 INITIAL RESULT WAS 7.2 AND THE REPEAT RESULT WAS 9.4. PATIENT SAMPLE 7 INITIAL RESULT WAS 7.9 AND THE REPEAT RESULT WAS 10.3. PATIENT SAMPLE 8 INITIAL RESULT WAS 7.2 AND THE REPEAT RESULT WAS 9.5. PATIENT SAMPLE 9 INITIAL RESULT WAS 7.6 AND THE REPEAT RESULT WAS 9.5. PATIENT SAMPLE 10 INITIAL RESULT WAS 7.4 AND THE REPEAT RESULT WAS 9.6. PATIENT SAMPLE 11 INITIAL RESULT WAS 7.2 AND THE REPEAT RESULT WAS 9.3. PATIENT SAMPLE 12 INITIAL RESULT WAS 7.4 AND THE REPEAT RESULT WAS 9.6. PATIENT SAMPLE 13 INITIAL RESULT WAS 7.6 AND THE REPEAT RESULT WAS 9.7. PATIENT SAMPLE 14 INITIAL RESULT WAS 7.5 AND THE REPEAT RESULT WAS 9.7. PATIENT SAMPLE 15 INITIAL RESULT WAS 7.2 AND THE REPEAT RESULT WAS 9.4. PATIENT SAMPLE 16 INITIAL RESULT WAS 7.7 AND THE REPEAT RESULT WAS 10. PATIENT SAMPLE 17 INITIAL RESULT WAS 7.4 AND THE REPEAT RESULT WAS 9.7. PATIENT SAMPLE 18 INITIAL RESULT WAS 9.1 AND THE REPEAT RESULT WAS 11.4. PATIENT SAMPLE 19 INITIAL RESULT WAS 7.4 AND THE REPEAT RESULT WAS 9.3. PATIENT SAMPLE 20 INITIAL RESULT WAS 8.7 AND THE REPEAT RESULT WAS 10.6. PATIENT SAMPLE 21 INITIAL RESULT WAS 7.5 AND THE REPEAT RESULT WAS 9.6. PATIENT SAMPLE 22 INITIAL RESULT WAS 7.6 AND THE REPEAT RESULT WAS 9.8. PATIENT SAMPLE 23 INITIAL RESULT WAS 7.3 AND THE REPEAT RESULT WAS 9.2. PATIENT SAMPLE 24 INITIAL RESULT WAS 7.6 AND THE REPEAT RESULT WAS 9.5. PATIENT SAMPLE 25 INITIAL RESULT WAS 7.6 AND THE REPEAT RESULT WAS 9.7. PATIENT SAMPLE 26 INITIAL RESULT WAS 8.3 AND THE REPEAT RESULT WAS 10.2. PATIENT SAMPLE 27 INITIAL RESULT WAS 7.8 AND THE REPEAT RESULT WAS 9.8. PATIENT SAMPLE 28 INITIAL RESULT WAS 7.9 AND THE REPEAT RESULT WAS 9.6. PATIENT SAMPLE 29 INITIAL RESULT WAS 7.6 AND THE REPEAT RESULT WAS 9.4. PATIENT SAMPLE 30 INITIAL RESULT WAS 7.8 AND THE REPEAT RESULT WAS 9.5. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE USER STATED THEY HAD TO AMEND ABOUT 70 REPORTS. THE USER STATED SHE BELIEVED NO PATIENTS WERE ADVERSELY AFFECTED AS THE PATIENT SAMPLES WERE FROM PHYSICIANS' OFFICES AND ALL OF THEM WERE TESTED AND RESULTED AFTER THE OFFICES HAD CLOSED. THE CALCIUM R2 REAGENT LOT NUMBER WAS 63783301. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CALCIUM REAGENT NEEDED RECALIBRATION. THE REAGENT WAS RECALIBRATED AND THE PERFORMANCE WAS VERIFIED BY RUNNING A SUCCESSFUL PRECISION CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALCIUM CRESOLPHTHALEIN COMPLEXONE, CALCIUM CIC ROCHE DIAGNOSTICS NA 63886201

    Patients

    Seq Age Sex Outcome Treatment
    1