BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOS2 PHOSPHATE (INORGANIC) VER.2

    MDR report key: 12631537 · Received October 14, 2021

    Report

    Report Number
    1823260-2021-02982
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 11, 2021
    Report Date
    October 14, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEO
    UDI-DI
    04015630918973
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALARM TRACE REVEALED ABNORMAL ASPIRATION ALARMS, LOW DEGASSER PRESSURE AND INSUFFICIENT DETERGENT ALARMS AROUND THE TIME OF THE EVENT. CALIBRATION AND QC DATA USING THE OLD REAGENT PACK WERE REVIEWED. CALIBRATION DATA ON 12-SEPT-2021 REVEALED THAT SIGNAL ONE WAS ABOUT TWO TIMES HIGHER THAN PREVIOUS SIGNALS. QC DATA ON 13-SEPT-2021 WAS NOTED TO BE VERY LOW. THE CONSUMABLE OR REAGENT PACK WAS NOTED TO HAVE CAUSED THE ISSUE, AS EVIDENCED BY THE IMPROVEMENT OF CALIBRATION, QC AND PATIENT RESULTS WHEN IT WAS REPLACED BY THE USER. THE USER PERFORMED CORRELATION TESTS WITH ACCEPTABLE RESULTS. THE FIELD SERVICE ENGINEER FURTHER INSPECTED THE RINSE LEVEL AND GEAR PUMP PRESSURE. HE RAN PRECISION TESTS FOR PHOSPHATE ACCORDING TO PRECISION GUIDELINES, WHICH REVEALED ACCEPTABLE RESULTS. QC WAS PERFORMED BY THE USER AND WAS NOTED TO BE WITHIN NORMAL RANGES. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE CUSTOMER'S ACTIONS (REPLACING THE REAGENT) ALONG WITH THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE RESULTS FOR PHOS2 PHOSPHATE (INORGANIC) VER.2 TESTED ON A COBAS 6000 C (501) MODULE. FROM (B)(6) 2021, 38 PATIENT SAMPLES WITH LOW PHOSPHATE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2021, THE QC WAS NOTED TO BE VERY LOW. THE REPORTER REPLACED THE REAGENT PACK WITH THE SAME LOT NUMBER IN THE ANALYZER, RECALIBRATED AND RERAN THE QC. SHE THEN RERAN THE SAME PATIENT SAMPLES ON THE ANALYZER FOR CORRECTION. THE REPORTER WAS ABLE TO PROVIDE AN EXAMPLE OF DISCREPANT RESULTS FOR ONE PATIENT SAMPLE. ON (B)(6) 2021, THE INITIAL RESULT WAS 0.7 MG/DL (THE EXACT DATE OF SAMPLE PROCESSING WAS NOT CLEARLY STATED, BUT (B)(6) 2021 WAS USED AS THIS WAS THE DATE THE SPECIMEN WAS COLLECTED). ON (B)(6) 2021, THE REPEAT RESULT WAS 3.0 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. THE C501 MODULE SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534548 PHOS2 PHOSPHATE (INORGANIC) VER.2 PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS CEO ROCHE DIAGNOSTICS NA 54801701 04015630918973

    Patients

    Seq Age Sex Outcome Treatment
    1