BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 15521767 · Received September 30, 2022

    Report

    Report Number
    3007111389-2022-00101
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    September 6, 2022
    Report Date
    November 30, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER-THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED FROM BIORAD SPECIALTY IMMUNOASSAY QUALITY CONTROL LOT 64920, MAS QUALITY CONTROL LOT OIM 24111A, AND 4 PATIENT SAMPLES TESTED USING VITROS IPTH LOTS 1610 AND 1645 ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. NO INFORMATION WAS CONFIRMED REGARDING THE HANDLING & STORAGE OF THE PATIENT SAMPLES BETWEEN VITROS IPTH TESTING EVENTS USING LOTS 1570, 1610, AND 1645. IN ADDITION, THE CUSTOMER COULD NOT PROVIDE THE DATE OF IPTH TESTING ON THE NON-VITROS ABBOTT IPTH METHOD. IT IS POSSIBLE THAT IMPROPER STORAGE AND HANDLING OF THE PATIENT SAMPLES BETWEEN THE TESTING EVENTS CONTRIBUTED TO THE LOWER-THAN-EXPECTED VITROS IPTH RESULTS. AN IPTH METHOD TO METHOD DIFFERENCE COULD BE A CONTRIBUTING FACTOR, AS THE VITROS IPTH REFERENCE INTERVAL IS 10 - 20 PG/ML AND THE ABBOTT IPTH REFERENCE INTERVAL IS 8.7 - 77.1 PG/ML. THERE IS NO INDICATION OF AN INSTRUMENT MALFUNCTION AND UNEXPECTED INSTRUMENT PERFORMANCE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. A REVIEW OF IPTH COMPLAINTS INDICATE AN INCREASE IN THE COMPLAINT RATE FOR ACCURACY LOW USING MULTIPLE VITROS IPTH REAGENT LOTS. ORTHO HAS INITIATED AN INVESTIGATION FOR LOWER-THAN-EXPECTED RESULTS OBTAINED FROM MULTIPLE VITROS IPTH REAGENT LOTS TESTED ON MULTIPLE VITROS INSTRUMENT PLATFORMS. EMAIL ADDRESS FOR CONTACT OFFICE ABOVE IS (B)(6).

    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 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. PLEASE REFER TO REPORT #3007111389-11/17/2022-001-C.

    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 BIORAD SPECIALTY IMMUNOASSAY QUALITY CONTROL LOT 64920, MAS QUALITY CONTROL LOT OIM 24111A, AND 4 PATIENT SAMPLES TESTED USING VITROS IPTH LOTS 1610 AND 1645 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS IPTH LOT 1610: BIORAD LOT 64920 L1 = 12.85, 12.92, 13.06, 13.83, 13.85, 14.05, 14.06 PG/ML VERSUS EXPECTED (BASELINE MEAN) OF 21.00 PG/ML, PATIENT 1, VITROS IPTH LOT 1610 = 17.85 PG/ML VERSUS EXPECTED (LOT 1570) OF 40.60 PG/ML, PATIENT 3, VITROS IPTH LOT 1610 = 25.4 PG/ML VERSUS ABBOTT IPTH RESULT OF 36.7 PG/ML, PATIENT 6, VITROS IPTH LOT 1610 = 21.3 PG/ML VERSUS ABBOTT IPTH RESULT OF 31.1 PG/ML, PATIENT 7, VITROS IPTH LOT 1610 = 8.3 PG/ML VERSUS ABBOTT IPTH RESULT OF 97.6 PG/ML. VITROS IPTH LOT 1645: MAS LOT OIM 24111A L1 = 16.0 PG/ML VERSUS EXPECTED (BASELINE MEAN) OF 29.4 PG/ML, MAS LOT OIM 24111A L2 = 56.7 PG/ML VERSUS EXPECTED (BASELINE MEAN) OF 89.2 PG/ML, MAS LOT OIM 24111A L3 = 1090.0 PG/ML VERSUS EXPECTED (BASELINE MEAN) OF 1599 PG/ML, PATIENT 1, VITROS IPTH LOT 1645 = 16.00 PG/ML VERSUS EXPECTED (LOT 1570) OF 40.60 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 WERE NOT REPORTED FROM THE LABORATORY AND THERE WAS NO REPORTED 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).

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2646994 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS 1645

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown