BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 15507839 · Received September 29, 2022

    Report

    Report Number
    3007111389-2022-00095
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    August 31, 2022
    Report Date
    November 30, 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 (B)(4). THE COMMUNICATION INDICATES THAT WHEN USING THE AFFECTED LOTS OF VITROS IPTH REAGENT PACK INTRAOPERATIVELY, PATIENT SAMPLES SHOULD BE TESTED USING THE SAME REAGENT LOT AND QC MATERIAL FOR BASELINE AND THROUGHOUT THE PROCEDURE. WHEN PERFORMING PATIENT SAMPLE TESTING USING THE AFFECTED LOTS OF VITROS IPTH REAGENT PACK, ADJUST YOUR LABORATORY¿S REFERENCE INTERVAL BY (B)(4). 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. ORTHO IS IN THE PROCESS OF MANUFACTURING NEW REAGENT LOTS WITH AN ANTICIPATED RELEASE IN DECEMBER 2022. UNTIL A NEW LOT OF VITROS IPTH REAGENT PACK IS AVAILABLE, BE AWARE THAT THE POTENTIAL EXISTS TO OBSERVE NEGATIVELY BIASED RESULTS WHEN USING THE AFFECTED LOTS OF VITROS IPTH LISTED ABOVE. THE FDA WAS NOTIFIED OF THIS ISSUE ON 17 NOVEMBER 2022. REFER TO REPORT #3007111389-11/17/2022-001-C.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES AND TWO DIFFERENT LEVELS OF NON-VITROS BIORAD SPECIALTY IMMUNOASSAY CONTROLS LOT 64910 CONTROLS GENERATED FROM TWO DIFFERENT REAGENT LOTS TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION DETERMINED THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT IS A PERFORMANCE ISSUE WITH VITROS IPTH REAGENT LOTS 1610 AND 1621. ACCEPTABLE RESULTS WERE OBTAINED FROM THE SAME PATIENT SAMPLES USING ALTERNATE VITROS IPTH REAGENT LOTS. AN INSTRUMENT RELATED PERFORMANCE ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT AS ACCEPTABLE RESULTS WERE OBTAINED USING ALTERNATE VITROS IPTH REAGENT LOTS WITHOUT PERFORMING ANY ACTIONS TO THE VITROS 5600 INTEGRATED SYSTEM. IMPROPER SAMPLE STORAGE DID NOT LIKELY CONTRIBUTE TO THE EVENT AS THE AFFECTED SAMPLES WERE STORED PER THE VITROS IPTH INSTRUCTIONS FOR USE. EMAIL ADDRESS FOR CONTACT OFFICE ABOVE 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 THREE OF FIVE SUPPLEMENTAL MDR¿S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE 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 DIFFERENT PATIENT SAMPLES AND TWO DIFFERENT LEVELS OF NON-VITROS BIORAD SPECIALTY IMMUNOASSAY CONTROLS LOT 64910 CONTROLS GENERATED FROM TWO DIFFERENT REAGENT LOTS TESTED ON A VITROS 5600 INTEGRATED SYSTEM. VITROS IPTH REAGENT LOT 1610. CORRELATION SAMPLE 2 VITROS IPTH RESULT OF 29.1 PG/ML VS. THE EXPECTED RESULT OF 45.3 PG/ML. BIORAD LOT 64910 LEVEL 1 RESULTS OF 14.27, 14.77 AND 15.24 PG/ML VS. THE EXPECTED RESULT OF 22.4 PG/ML. VITROS IPTH REAGENT LOT 1621. CORRELATION SAMPLE 7 VITROS IPTH RESULT OF 79.2 PG/ML VS. THE EXPECTED RESULT OF 115.9 PG/ML. BIORAD LOT 64910 LEVEL 1 RESULTS OF 13.25, 14.64, 14.80, 14.63 AND 14.65 PG/ML VS. THE EXPECTED RESULT OF 22.4 PG/ML. BIORAD LOT 64910 LEVEL 3 RESULTS OF 462.26 AND 460.32 PG/ML VS. THE EXPECTED RESULT OF 666.9 PG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VITROS IPTH RESULTS OBTAINED FROM THE CORRELATION SAMPLES AND THE BIORAD QC FLUIDS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF FIVE MDR¿S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE 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
    1922256 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS 1610

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown