BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA2 CALCIUM GEN.2

    MDR report key: 6067298 · Received October 31, 2016

    Report

    Report Number
    1823260-2016-01678
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    October 3, 2016
    Report Date
    January 17, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHW
    PMA / PMN Number
    K113521
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THE NEXT SAMPLE FROM THE PATIENT PRODUCED A NORMAL CALCIUM RESULT (NO DATA WERE PROVIDED), AND SAID THAT, "...WHATEVER WAS INTERFERING IS OUT OF THE PATIENT'S SYSTEM." THE CUSTOMER REFUSED FURTHER FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FROM 1 PATIENT WHEN TESTED ON COBAS 8000 C701 ANALYZERS. THE INITIAL SERUM SAMPLE WAS DRAWN AS A PRE-RENAL DIALYSIS SAMPLE ON (B)(6) 2016. THE INITIAL CALCIUM WAS 1.9 MG/DL. IT WAS REPEATED ON OTHER C701 ANALYZERS WITH COMPARABLE RESULTS. THE SPECIFIC RESULTS WERE REQUESTED BUT NOT PROVIDED. A SECOND PRE-DIALYSIS SERUM SAMPLE WAS DRAWN ON (B)(6) 2016 AND PRODUCED A CALCIUM RESULT OF 1.6 MG/DL. IT WAS ALSO REPEATED OTHER C701 ANALYZERS WITH COMPARABLE RESULTS. THE SPECIFIC RESULTS WERE REQUESTED BUT NOT PROVIDED. A THIRD PRE-DIALYSIS SAMPLE WAS DRAWN ON (B)(6) 2016 AT ANOTHER FACILITY (METHOD UNKNOWN); THE CALCIUM WAS IN THE NORMAL RANGE. THE PATIENT WAS SENT TO DIALYSIS. ON ABOUT (B)(6) 2016 THE CUSTOMER POOLED THE SMALL SERUM VOLUMES REMAINING FROM THE FIRST 2 SAMPLES FROM (B)(6) 2016 (CALCIUM OF 1.9 AND 1.6 MG/DL) AND SENT THEM TO ANOTHER LABORATORY WHERE THE POOL WAS TESTED ON A BECKMAN AU ANALYZER. THE CALCIUM WAS 5.6 MG/DL ON THE POOL. THE CUSTOMER RECEIVED A POST-DIALYSIS LITHIUM HEPARIN SAMPLE DRAWN ON (B)(6) 2016; THE CALCIUM RESULT ON THE C701 ANALYZER WAS 8.9 MG/DL. ON (B)(6) 2016 SERUM AND LITHIUM HEPARIN SAMPLES WERE DRAWN. THE SERUM WAS TESTED ON THE C701 ANALYZER WITH A RESULT OF 5.4 MG/DL. THE LITHIUM HEPARIN SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED BY AN UNKNOWN METHOD WITH A RESULT OF 8.1 MG/DL THE PATIENT WAS NOT ADVERSELY AFFECTED. ONE OF THE C701 ANALYZERS HAD SERIAL NUMBER (B)(4). THE SERIAL NUMBERS OF THE OTHER C701 ANALYZERS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717767 CA2 CALCIUM GEN.2 TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM CHW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 CALCITROL