MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH II REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	6900052
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that lower than expected vitros intact pth ii (ipth ii) results were obtained from several different patient samples when tested using vitros ipth ii reagent on a vitros xt 7600 integrated system.The samples were considered discordant when compared to a non-vitros diasorin method.A definitive assignable cause of the lower than expected vitros ipth result could not be determined.Vitros ipth ii reagent was a new reagent for the customer which is currently being validated to bring testing in house.Therefore, no previous vitros ipth ii reagent lots of qc testing were available for evaluation.However, based on quality control (qc) results processed after the events, a vitros ipth ii lot 0040 and lot 0050 performance issue is not a likely contributor to the event.A diagnostic precision test using vitros total thyroid control (ttc) fluids was not performed to confirm the performance of the vitros analyzer.Therefore, an instrument cannot be entirely ruled out as a potential contributor to the events.Furthermore, it was not possible to establish if the customer was following the sample collection device manufacturer's recommendation for centrifugation protocol; therefore, pre-analytical sample processing cannot be ruled out as a contributing factor.It is possible that cellular debris due to poor sample preparation was present in the affected samples, although this cannot be confirmed.Additionally, the ortho tsc were able to determine that the patient's samples were stored frozen between the testing events and processed at the reference lab the same day or the following day.As per the vitros ipth ii ifu, specimen collection and preparation storage section: "intact pth is labile and susceptible to fragmentation.Correct handling of patient samples is necessary to ensure that the pth molecule remains intact.The degree of fragmentation will depend on both time and temperature of storage." however, no information was provided with regards to the handling of the patient's samples on the day of the event or at the reference lab, therefore, it is possible improper handling of the patient's samples contributed to the lower than expected vitros ipth ii lot 0040 and lot 0050 results, although this could not be confirmed.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ipth reagent lot 0040 and lot 0050.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros intact pth ii (ipth ii) results were obtained from several different patient samples when tested using vitros ipth ii reagent on a vitros xt 7600 integrated system.The samples were considered discordant when compared to a non-vitros diasorin method.Patient 1 result of 48.99 pg/ml vs an expected result of 76.00 pg/ml patient 4 result of 22.99 pg/ml vs an expected result of 41.00 pg/ml patient 5 result of 49.19 pg/ml vs an expected result of 83.00 pg/ml patient 7 result of 25.03 pg/ml vs an expected result of 40.00 pg/ml patient 8 result of 69.75 pg/ml vs an expected result of 135.00 pg/ml patient 10 result of 80.19 pg/ml vs an expected result of 151.00 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 patient sample results were obtained while performing an ipth ii comparison study and was not reported from the laboratory.There was no allegation of harm as a result of the event.This report is number one of two mdrs 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 numbers (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH II REAGENT PACK
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 19982251
• Report Number: 3007111389-2024-00155
• Device Sequence Number: 8141352
• Product Code: CEW
• UDI-Device Identifier: 10758750032709
• UDI-Public: (01)10758750032709(17)23092024(11)02012024(10)0040
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2024
• Device Catalogue Number: 6900052
• Device Lot Number: 0040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown