BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 15569144 · Received October 10, 2022

    Report

    Report Number
    3007111389-2022-00113
    Event Type
    Malfunction
    Date Received
    October 10, 2022
    Date of Event
    September 13, 2022
    Report Date
    November 30, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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%. 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 -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. ORTHO IS IN THE PROCESS OF MANUFACTURING NEW REAGENT LOTS WITH AN ANTICIPATED RELEASE IN (B)(6) 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. PLEASE REFER TO REPORT #3007111389-11/17/2022-001-C.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT LOWER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROLS PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS IPTH REAGENT LOT 1610 AND LOT 1645 ON A VITROS XT 7600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. AS VITROS IPTH LOTS 1610 AND 1645 WERE NEW REAGENT LOTS FOR THE CUSTOMER AT THE TIME OF THE EVENTS, NO HISTORICAL QC RESULTS WERE AVAILABLE FOR EVALUATION AND A REAGENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENT. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING INDICATES A POSSIBLE PERFORMANCE ISSUE WITH VITROS IPTH REAGENT LOTS 1610 AND 1645. ORTHO HAS INITIATED AN INVESTIGATION ((B)(4)) FOR LOWER THAN EXPECTED RESULTS OBTAINED FROM MULTIPLE VITROS IPTH REAGENT LOTS TESTED ON MULTIPLE VITROS INSTRUMENT PLATFORMS. WITHIN RUN PRECISION TESTING WAS NOT PROCESSED ON THE VITROS XT 7600 SYSTEM AND AN INSTRUMENT RELATED ISSUE CANNOT BE ENTIRELY RULED OUT. HOWEVER, HISTORICAL QC RESULTS FOR THE CUSTOMER¿S PREVIOUS LOT OF VITROS IPTH REAGENT IN COMBINATION WITH THE VITROS XT 7600 SYSTEM WERE WITHIN EXPECTATIONS INDICATING THAT AN INSTRUMENT RELATED ISSUE IS NOT LIKELY A CONTRIBUTING FACTOR OF THE EVENT. (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 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).

    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 OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROLS PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS IPTH REAGENT LOT 1610 AND LOT 1645 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS IPTH LOT 1610: BIORAD LOT 64940 LEVEL 1 RESULT OF 16.22 PG/ML VS AN EXPECTED RESULT OF 23.71 PG/ML. VITROS IPTH LOT 1645: BIORAD LOT 64940 LEVEL 1 RESULTS OF 14.96 AND 15.39 PG/ML VS AN EXPECTED RESULT OF 23.71 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 FROM A QUALITY CONTROL FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER MADE NO INDICATION THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED. 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
    1560203 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS 1645

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown