BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 70X CREATININE (ENZYMATIC)/600

    MDR report key: 3033352 · Received April 3, 2013

    Report

    Report Number
    1823260-2013-02013
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    August 8, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K024098
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6). FOR THE MEDWATCH FOR THE C702 ANALYZER REFERRED TO AS 702B, REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. THE SAMPLES WERE TESTED USING RETENTION PACKS OF THE LOTS INVOLVED IN THE EVENT AND ANOTHER LOT OF REAGENT ON A C701 AND C501 ANALYZER. THE CUSTOMER'S RESULTS WERE REPRODUCED, BUT ONLY WITH THE LOTS OF REAGENTS INVOLVED IN THIS EVENT. AS THE CUSTOMER DID NOT OBSERVE THE HIGH CREATININE RESULTS WHEN THE PATIENTS HAD NEW SAMPLES TESTED AFTER THE PATIENTS DISCONTINUED THEIR MEDICATIONS, A DRUG INTERFERENCE COULD BE THE REASON FOR THE OBSERVED EFFECT. DRUG INTERFERENCE TESTING WAS PERFORMED AND A SPECIFIC INTERFERENCE COULD NOT BE IDENTIFIED. ADDITIONAL SAMPLE WAS NOT AVAILABLE FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE CREATININE PLUS VER.2 (CREA) RESULTS ON THEIR C702 ANALYZER (702A). IT WAS UNKNOWN EXACTLY HOW MANY PATIENT SAMPLES WERE INVOLVED IN THIS EVENT. THE UNITS OF MEASURE WERE MG/DL. REPEATING TESTING WAS ALSO PERFORMED USING ANOTHER C702 ANALYZER (702B), A MODULAR ANALYTICAL P-MODULE, A COBAS 6000 C501 MODULE. THE SERIAL NUMBERS WERE NOT PROVIDED FOR THE REPEAT ANALYZERS. THE CUSTOMER PROVIDED (B)(4) AS THE SERIAL NUMBER FOR ONE OF THE C702 ANALYZERS, BUT IT WAS UNKNOWN WHICH C702 ANALYZER. REPEAT TESTING WAS ALSO PERFORMED USING THE CREATININE JAFFE (CREJ) REAGENT, LOT NUMBER 671603 AND THE EXPIRATION DATE WAS NOT PROVIDED. PLEASE REFER TO THE ATTACHMENT TO THE MEDWATCH FOR THE PATIENT DATA. THE CUSTOMER STATED THE RESULTS FROM THE P-MODULE FIT THE CLINICAL STATUS AND PREVIOUS RESULTS OF THE PATIENT FROM (B)(6) 2013. THE CUSTOMER CONSIDERED THE RESULTS FROM THE P-MODULE TO BE CORRECT. THE CUSTOMER STATED THAT INCORRECT RESULTS WERE INITIALLY REPORTED, BUT CORRECTED THE NEXT DAY. IT WAS UNKNOWN WHICH RESULTS WERE REPORTED. THERE WERE NO REPORTS OF ANY ADVERSE EVENTS. THE CREA REAGENT LOT NUMBER WAS 676439 AND THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136065 COBAS C 70X CREATININE (ENZYMATIC)/600 ENZYMATIC METHOD, CREATININE20 JFY ROCHE DIAGNOSTICS NA 676439

    Patients

    Seq Age Sex Outcome Treatment
    1 016 YR PATIENT FROM (B)(6) 2013 STRATTERA| PATIENT FROM (B)(6) 2013 DIPI| PATIENT FROM (B)(6) 2013 MEXALEN| PATIENT FROM (B)(6) 2013 PANTOLOC| PATIENT FROM (B)(6) 2013 LOVENOX| PATIENT FROM (B)(6) 2013 LAEVOLAC| PATIENT FROM (B)(6) 2013 PERFALGAN| PATIENT FROM (B)(6) 2013 DICLOBENE| PATIENT FROM (B)(6) 2013 NAVOBAN