BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 15711955 · Received November 1, 2022

    Report

    Report Number
    3007111389-2022-00192
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Date of Event
    August 24, 2022
    Report Date
    December 1, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MDR WAS CREATED TO UPDATE THE ROOT CAUSE FOR THE LOWER THAN EXPECTED VITROS IPTH RESULTS. ORTHO'S INVESTIGATION HAS IDENTIFIED THE ROOT CAUSE OF THIS ISSUE STEMS FROM A RAW MATERIAL USED IN THE AFFECTED LOTS. A COMMUNICATION (CL2022-275) WAS SENT ON 17 NOVEMBER 2022 TO ALL CUSTOMERS WHO HAVE BEEN SHIPPED VITROS IPTH REAGENT PACK WITHIN THE PREVIOUS 12 MONTHS. THE COMMUNICATION INFORMED CUSTOMERS THAT WHEN PERFORMING PATIENT SAMPLE TESTING USING THE AFFECTED IPTH LOTS (1610, 1621, 1630, 1640, 1645, 1650, 1670), CUSTOMERS MAY EXPERIENCE AN AVERAGE NEGATIVE BIAS OF APPROXIMATELY -12%. IN ADDITION, A VARIABLE NEGATIVE SHIFT IN PERFORMANCE WAS ALSO CONFIRMED USING BIORAD LIQUICHECK/LYPHOCHECK SPECIALTY IMMUNOASSAY CONTROLS AND THERMO SCIENTIFIC MAS OMNI IMMUNE IMMUNOASSAY CONTROLS WHEN COMPARED TO THEIR PUBLISHED ASSIGNED VALUES. ORTHO HAS ASSIGNED NEW MEAN AND SD VALUES FOR AVAILABLE BIORAD AND THERMO FISHER CONTROL LOTS FOR USE SPECIFICALLY WITH THE AFFECTED LOTS LISTED IN THE COMMUNICATION. THE FDA WAS NOTIFIED OF THIS ISSUE ON 17 NOVEMBER 2022. PLEASE REFER TO REPORT # (B)(4).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT LOWER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUID WHEN TESTED USING VITROS IPTH LOT 1610 ON A VITROS XT7600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. HISTORICAL VITROS IPTH LOT 1610 QC RESULTS OBTAINED USING BIORAD CONTROLS WERE NOT WITHIN EXPECTATION WHEN COMPARED TO THE BIORAD PEER MEAN VALUES SUGGESTING A VITROS IPTH REAGENT ISSUE WAS A POTENTIAL CONTRIBUTING FACTOR. HOWEVER, VITROS IPTH LOT 1610 RESULTS USING VITROS IPTH CONTROL FLUIDS WERE ACCEPTABLE. THERE WAS NO EVIDENCE TO SUGGEST AN INSTRUMENT MALFUNCTION. HOWEVER, WITHIN RUN PRECISION TESTING WAS NOT PROCESSED ON THE VITROS XT7600 SYSTEM, THEREFORE AN INSTRUMENT RELATED ISSUE CANNOT BE ENTIRELY RULED OUT. ORTHO HAS INITIATED AN INVESTIGATION FOR LOWER THAN EXPECTED RESULTS OBTAINED FROM MULTIPLE VITROS IPTH REAGENT LOTS TESTED ON MULTIPLE VITROS INSTRUMENT PLATFORMS. A VITROS IPTH LOT 1610 REAGENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. CONTINUAL TRACKING AND TRENDING INDICATES A POSSIBLE PERFORMANCE ISSUE WITH VITROS IPTH REAGENT LOT 1610. EMAIL ADDRESS FOR CONTACT OFFICE IS (B)(6).

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL MDR WAS CREATED TO UPDATE THE ROOT CAUSE OF THE LOWER THAN EXPECTED VITROS IPTH RESULTS. IN ADDITION, THE IPTH ISSUE WAS REPORTED AS A CLASS II RECALL AND A COMMUNICATION WAS SENT TO CUSTOMERS. THIS REPORT IS NUMBER TWO OF TWO SUPPLEMENTAL MDRS FOR THIS EVENT. TWO 3500A FORMS WERE SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4)..

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUID WHEN TESTED USING VITROS IPTH LOT 1610 ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD LEVEL 1 LOT 64940 RESULTS OF 15.7, 14.3, 14.5, 15.0, 14.5, 14.5, 15.7, 15.2, 15.4, 15.4, AND 15.1 PG/ML VERSUS THE PEER MEAN RESULT OF 22.41 PG/ML BIORAD LEVEL 2 LOT 64940 RESULTS OF 123.0, 124.1, 120.0, 120.2, 117.7, 117.3, 127.8, AND 125.9 PG/ML VERSUS THE PEER MEAN RESULT OF 182.8 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED FROM QC FLUIDS AND WERE NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512563 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS 1610

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown