BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 3233444 · Received July 18, 2013

    Report

    Report Number
    1319681-2013-00142
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    March 20, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, NON-REPRODUCIBLE, UNEXPECTED, VITROS IPTH QUALITY CONTROL AND PATIENT SAMPLE RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION DETERMINED THE FOLLOWING CONCLUSIONS: QC RESULTS OBTAINED USING VITROS IPTH LOT 0290 AND QC FLUID L2: THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. AN INSTRUMENT RELATED, A REAGENT RELATED ISSUE, QUALITY CONTROL FLUID IN USE, A PRE-ANALYTICAL SAMPLE MIX UP CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. (3500A FOR VITROS IPTH LOT 0290); QC RESULTS OBTAINED USING VITROS IPTH LOT 0330 AND QC FLUID L1: THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. REAGENT PACK, QUALITY CONTROL FLUID IN USE, A PRE-ANALYTICAL SAMPLE MIX UP CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THERE WAS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. (3500A FOR VITROS IPTH LOT 0330); QC AND PATIENT SAMPLE RESULTS OBTAINED USING VITROS IPTH LOT 0330 AND QC FLUID L2, L3: THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT IS USER ERROR, THE USE OF AN UNVERIFIED IPTH CALIBRATION (3500A FOR VITROS 5600); SINGLE PATIENT SAMPLE RESULT USING VITROS IPTH LOT 0330: THE AGE OF THE SAMPLE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE EVENT. (3500A FOR VITROS IPTH LOT 0330).

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED MULTIPLE, NON-REPRODUCIBLE, UNEXPECTED VITROS IPTH QUALITY CONTROL AND PATIENT SAMPLE RESULTS ON A VITROS 5600 INTEGRATED SYSTEM. THE FOLLOWING RESULTS WERE OBTAINED: VITROS IPTH LOT 0290: VITROS QC FLUID L2 = 119.8, 57.0 VS. AN EXPECTED RESULT = 204.9 PG/ML. VITROS IPTH LOT 0330. QC RESULTS: VITROS QC FLUID L1 = 7.1, 9.8 VS. AN EXPECTED RESULT = 24.2 PG/ML; VITROS QC FLUID L2 = 309.9, 299.0, 299.1, 290.1, 286.7, 294.0, 290.7, 283.1, 278.0, 283.2, 275.5, 279.6 VS. AN EXPECTED RESULT = 204.9 PG/ML; VITROS QC FLUID L3 = 886.0, 868.0, 853.8, 830.1, 835.7, 864.8, 820.8, 832.7, 802.4, 820.9, 810.2, 812.1, 805.1, 807.3, 807.7, 798.7, 801.2 VS. AN EXPECTED RESULT = 608.0 PG/ML. PATIENT RESULTS: SAMPLE 1 = 106.7 VS. AN EXPECTED RESULT = 55.0 PG/ML; SAMPLE 2 = 208.0 VS. AN EXPECTED RESULT = 111.0 PG/ML; SAMPLE 3 = 58.1 VS. AN EXPECTED RESULT = 36.0 PG/ML; SAMPLE 4 = 62.8 VS. AN EXPECTED RESULT = 43.0 PG/ML; SAMPLE 5 = 208.9 VS. AN EXPECTED RESULT = 111.9 PG/ML; SAMPLE 7 = 106.7 VS. AN EXPECTED RESULT = 55.9 PG/ML; SAMPLE 8 = 124.8 VS. AN EXPECTED RESULT = 68.7 PG/ML; SAMPLE 9 = 157.1 VS. AN EXPECTED RESULT = 90.1 PG/ML; SAMPLE 10 = 146.2 VS. AN EXPECTED RESULT = 77.0 PG/ML; SAMPLE 12 = 136.8 VS. AN EXPECTED RESULT = 76.7 PG/ML; SAMPLE 14 = 81.3 VS. AN EXPECTED RESULT = 43.7 PG/ML; SAMPLE 15 = 98.6 VS. AN EXPECTED RESULT =67.5 PG/ML; SAMPLE 16 = 196.8 VS. AN EXPECTED RESULT = 103.7 PG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE CUSTOMER REPEAT TESTED ALL PATIENT SAMPLES AFFECTED BY AN ATYPICAL CALIBRATION. CORRECTED REPORTS WERE ISSUED FOR ALL AFFECTED PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOUR OF FOUR MDR¿S FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335101 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1