BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 15845951 · Received November 22, 2022

    Report

    Report Number
    3007111389-2022-00632
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    October 18, 2022
    Report Date
    December 1, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    CEW
    UDI-DI
    10758750006267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 #3007111389-11/17/2022-001-C.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT LOWER AND HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN NON-VITROS BIORAD QUALITY CONTROL (QC) FLUIDS WERE PROCESSED USING VITROS IPTH REAGENT LOTS 1605 AND 1621 WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED FOR THE HIGHER THAN EXPECTED BIORAD QC RESULTS OBTAINED FROM IPTH LOT 1605. IT IS POSSIBLE THAT THE BIORAD BASELINE MEAN IN USE WAS NOT APPROPRIATE FOR LOT 1605 BUT THERE WAS NO PEER DATA FOR COMPARISON TO CONFIRM IPTH QC PERFORMANCE. THE CUSTOMER DID NOT REPORT ANY CONCERN WITH PATIENT ACCURACY USING LOT 1605. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED FOR THE LOWER THAN EXPECTED BIORAD QC RESULTS OBTAINED FROM IPTH LOT 1621. A PATIENT COMPARISON WAS PERFORMED BETWEEN THE TWO IPTH LOTS AND THE LOT 1621 RESULTS WERE LOWER THAN THE LOT 1605 RESULTS. THE CUSTOMER DEEMED THE COMPARISON ACCEPTABLE BASED ON ACCEPTABLE RESULTS OBTAINED FROM VITROS IPTH QC RESULTS. ORTHO HAS INITIATED AN INVESTIGATION FOR LOWER THAN EXPECTED RESULTS OBTAINED FROM MULTIPLE VITROS IPTH REAGENT LOTS TESTED ON MULTIPLE VITROS INSTRUMENT PLATFORMS. AN INSTRUMENT RELATED PERFORMANCE ISSUE WAS NOT A LIKELY CONTRIBUTOR TO THE EVENT AS THE CUSTOMER GAVE NO INDICATION OF ANY INSTRUMENT MALFUNCTION. HOWEVER, AS NO TESTING WAS PERFORMED TO CONFIRM THE VITROS 5600 INSTRUMENT PERFORMANCE, AN INSTRUMENT ISSUE CANNOT BE COMPLETELY 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.

    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 FOUR MDR¿S FOR THIS EVENT. FOUR 3500A FORMS WERE SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. HOWEVER, DEVICE FOUR FOR THIS EVENT WAS FOR AN IPTH LOT NOT ASSOCIATED WITH THE RECALL, AND THEREFORE NO SUPPLEMENTAL MDR WILL BE SUBMITTED FOR DEVICE FOUR FOR THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 600040.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN NON-VITROS BIORAD QUALITY CONTROL (QC) FLUIDS WERE PROCESSED USING VITROS IPTH REAGENT LOTS 1605 AND 1621 WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. VITROS IPTH LOT 1605 BIORAD LEVEL 3 LOT 64930 RESULT OF 778.0, 783.8, 777.2, 766.5 AND 765.1 PG/ML VERSUS THE EXPECTED RESULT OF 585.3 PG/ML VITROS IPTH LOT 1621 BIORAD LEVEL 1 LOT 64930 RESULT OF 15.95, 15.40, 16.12, 15.00, 16.43, 16.74, 15.88, 16.65, 16.52, 15.17, 14.99 AND 15.41 PG/ML VERSUS THE EXPECTED RESULT OF 26.05 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 AND HIGHER THAN EXPECTED VITROS IPTH RESULTS OBTAINED 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 TWO OF FOUR MDR¿S FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4), (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917614 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS, INC. 6802892 1621 10758750006267

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown