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

Model Number	6802220
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a discordant, lower than expected b-hcg ii (b-hcg) result was obtained when a patient sample was tested using vitros b-hcg lot 3650 on a vitros eci q immunodiagnostic system.Patient 1, sample 1 result of < 2.39 miu/ml versus the expected result of 100 miu/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, lower than expected vitros b-hcg result was not reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that a discordant, lower than expected b-hcg ii (b-hcg) result was obtained when a patient sample was tested using vitros b-hcg lot 3650 on a vitros eci q immunodiagnostic system.A definitive cause of the event was not established with the limited information provided.There was limited historical qc data to assess vitros b-hcg lot 3650 performance and the customer only processes a single qc, therefore a vitros b-hcg lot 3650 reagent performance cannot be ruled out as a contributor to the event.However, the vitros b-hcg lot 3650 result from qc testing on the date of the event was acceptable and ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros b-hcg reagent lot 3650.It was not determined if the vitros eci q immunodiagnostic system was performing as expected around the time of the event, therefore an instrument issue cannot be ruled out as a contributor to the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor as it was not possible to determine whether the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.
Additional Manufacturer Narrative
The investigation determined that a discordant, lower than expected b-hcg ii (b-hcg) result was obtained when a patient sample was tested using vitros b-hcg lot 3650 on a vitros eci q immunodiagnostic system.A definitive cause of the event was not established with the limited information provided.There was limited historical qc data to assess vitros b-hcg lot 3650 performance and the customer only processes a single qc, therefore a vitros b-hcg lot 3650 reagent performance cannot be ruled out as a contributor to the event.However, the vitros b-hcg lot 3650 result from qc testing on the date of the event was acceptable and ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros b-hcg reagent lot 3650.It was not determined if the vitros eci q immunodiagnostic system was performing as expected around the time of the event, therefore an instrument issue cannot be ruled out as a contributor to the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor as it was not possible to determine whether the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.
Event or Problem Description
A supplemental emdr is being submitted, as an emdr initially sent for this event (b)(6), mfr report number: 3007111389-2023-00072, sent 16-may-2023) indicated the date of the event was 10-apr-2023.The correct date of event (as per section b3) is 28-mar-2023.----------------------------------------------------------------------------- a customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a discordant, lower than expected b-hcg ii (b-hcg) result was obtained when a patient sample was tested using vitros b-hcg lot 3650 on a vitros eci q immunodiagnostic system.Patient 1, sample 1 result of < 2.39 miu/ml versus the expected result of 100 miu/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, lower than expected vitros b-hcg result was not reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16944931
• Report Number: 3007111389-2023-00072
• Device Sequence Number: 6555317
• Product Code: DHA
• UDI-Device Identifier: 10758750002320
• UDI-Public: 10758750002320
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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: 09/08/2023
• Device Model Number: 6802220
• Device Catalogue Number: 6802220
• Device Lot Number: 3650
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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