BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C.F.A.S. PROTEINS

    MDR report key: 6797166 · Received August 16, 2017

    Report

    Report Number
    1823260-2017-01706
    Event Type
    Malfunction
    Date Received
    August 16, 2017
    Date of Event
    June 29, 2017
    Report Date
    December 13, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIX
    PMA / PMN Number
    K133330
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD COMPARISONS OF THE TWO CALIBRATOR LOTS WERE PERFORMED WITH PATIENT SAMPLES. ALL RESULTS WERE WITHIN SPECIFIED LIMITS.

    Additional Manufacturer Narrative · 1

    IN 2016, A NEW AAT REAGENT LOT (LOT 613722) HAD AN ELEVATED CONTROL RECOVERY OF ABOUT +8%. THIS WAS DETERMINED TO BE DUE TO A CHANGE IN THE ANTIBODY QUALITY IN THE REAGENT. HUMAN SAMPLES WERE NOT AFFECTED AND THERE WAS NO VIOLATION OF SPECIFICATIONS FOR THE REAGENT. NEW CFAS CALIBRATOR LOT 144344 WAS STANDARDIZED USING THIS NEW REAGENT LOT NUMBER (LOT 613722). AS A RESULT, THE NEW CFAS CALIBRATOR LOT 144344 SHIFTED +8%, IN TURN CAUSING A -8% SHIFT IN PATIENT RESULTS. THE OLD CFAS CALIBRATOR LOT (LOT 186510) WAS STANDARDIZED USING AN OLDER REAGENT LOT NUMBER. DURING INVESTIGATIONS, MEASUREMENTS WERE PERFORMED USING ONE C702 ANALYZER, ONE REAGENT PACK (LOT 193958), THREE CALIBRATORS (LOTS 186510, 144344, AND 199428), AND 13 SAMPLES PER CALIBRATION. RETENTION MATERIALS WERE USED. SAMPLES: 1 X ERM-DA470K-IFCC STANDARD, 1 X CFAS P LOT 186510, 1 X CFAS P LOT 144344, 1 X CFAS P LOT 199428, 1 X PCCC1 LOT 186373, 1 X PCCC2 LOT 160386, 5 X HUMAN SERA, 2 X HUMAN SERA, MANUALLY DILUTED WITH NACL. RESULT: CONTROLS: PCCC1 AND PCCC2 RECOVERED WITHIN 1 SD RANGE. MEASUREMENTS CALIBRATED WITH CFAS P 144344 AND CFAS P 199428 ARE COMPARABLE TO EACH OTHER, WHILE MEASUREMENTS CALIBRATED WITH CFAS P 186510 DIFFERS WHEN COMPARED TO MEASUREMENTS PERFORMED WITH THE OTHER CFAS LOTS. MEASUREMENTS CALIBRATED WITH CFAS P 186510 SHOW A DIFFERENCE OF AROUND 6-8% TO THE MEASUREMENTS CALIBRATED WITH CFAS P 144344 AND 199428. AAT IS TRACEABLE TO ERM-DA470K-IFCC. ERM-DA470K-IFCC RECOVERY IS WITH CFAS P 144344 AND 199428 QUITE LOW WHILE WITH CFAS P 186510 RECOVERY IS AROUND 100%. QUALITY CONTROL RECOVERY IS WITHIN CRITERIA OF +/- 10%. HUMAN SERA COMPARISON IS > 10% DIFFERENCE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4). EXPIRATION DATE WAS PROVIDED AS NOVEMBER 2018.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR AAT2 TINA-QUANT ¿1-ANTITRYPSIN VER.2 (AAT) ON A COBAS 8000 C 702 MODULE (C702). THE CUSTOMER COMPLAINS ABOUT PATIENT SAMPLE RECOVERY WITH A NEW C.F.A.S. PROTEINS (CFAS) CALIBRATOR LOT NUMBER, 14434401. THE CUSTOMER RAN A COMPARISON OF THE OLD CFAS CALIBRATOR LOT (186510) TO THE NEW CFAS LOT USING 40 PATIENT SAMPLES. PATIENT SAMPLES WERE TESTED USING THE NEW CALIBRATOR LOT ON THE C702 ANALYZER AND THE SAME SAMPLES WERE TESTED ON A DIFFERENT ANALYZER USING THE OLD CALIBRATOR LOT. THE CUSTOMER RAN THE SAMPLES ON BOTH ANALYZERS WITHIN A SHORT PERIOD OF TIME. THERE WAS AN 11.5% DIFFERENCE IN PATIENT VALUES WHEN COMPARING THE RESULTS OBTAINED WITH THE DIFFERENT CALIBRATORS. THE CUSTOMER IS CONCERNED BECAUSE THERE IS A DIRECT RELATION BETWEEN THE AAT RESULTS OF PATIENT SAMPLES AND TREATMENT THAT THEIR PATIENTS RECEIVE. OF THE 40 PATIENT SAMPLES, ONE HAD AN ERRONEOUS RESULT. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE RESULTED WITH AN AAT VALUE OF 1.23 G/L WHEN TESTED ON THE C702 ANALYZER USING THE NEW CALIBRATOR LOT. THE SAMPLE RESULTED AS 0.86 G/L WHEN TESTED ON THE OTHER ANALYZER USING THE OLD CALIBRATOR LOT. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE AAT REAGENT LOT NUMBER WAS ASKED FOR, BUT NOT PROVIDED. THE C702 ANALYZER SERIAL NUMBER WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577215 C.F.A.S. PROTEINS CALIBRATOR, MULTI-ANALYTE MIXTURE JIX ROCHE DIAGNOSTICS NA 14434401

    Patients

    Seq Age Sex Outcome Treatment
    1