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

Model Number	6801322
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that discordant, negative hbsag results were obtained when wisconsin state laboratory of hygiene (wslh) proficiency samples were tested using vitros hbsag lot: 9000, lot: 9020 and lot: 9130 from three separate proficiency testing events on a vitros eci q immunodiagnostic system.A definitive cause of the false negative vitros hbsag results was not determined.A vitros hbsag lot: 9000 and 9020 reagent issue cannot be completely ruled out as a contributor to the event as no historical qc results were provided for the time of the events.However, the customer indicated that vitros hbsag lot: 9000 and lot: 9020 results were acceptable on the day of wslh proficiency testing.Qc results were provided by the customer for vitros hbsag lot: 9130 and were acceptable on the date of testing.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros hbsag lot: 9000, lot: 9020 or lot: 9130.An instrument related issue is an unlikely contributor to the events as the wslh report indicated all vitros users were not scored due to the discordant, negative vitros hbsag results obtained by all vitros users.An issue with the matrix of the wslh proficiency samples cannot be ruled out as a contributor to the events, as no information was provided in relation to the composition of the wslh proficiency samples.Additionally, the presence of a sample interferent in the affected wslh proficiency samples cannot be ruled out as contributing to the events.Furthermore, the use of azide as a preservative in the samples also cannot be ruled out as a contributor to the discordant, negative vitros hbsag results obtained.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, negative hbsag results were obtained when wisconsin state laboratory of hygiene (wslh) proficiency samples were tested using vitros hbsag lot: 9000, lot: 9020 and lot: 9130 from three separate proficiency testing events on a vitros eci q immunodiagnostic system.Vitros hbsag lot 9000, wslh sample yb-6 result of 0.03 s/c (negative) versus the expected result of positive vitros hbsag lot 9000, wslh sample yb-7 result of 0.45 s/c (negative) versus the expected result of positive vitros hbsag lot: 9020, wslh sample yb-14 result of 0.51 s/c (negative) versus the expected result of positive vitros hbsag lot 9130, wslh sample yb-5 result of 0.02 s/c (negative) versus the expected result of positive biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The discordant, negative vitros hbsag results were generated when the customer was running non-patient fluids.Ortho has not been made aware of any 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 numbers: (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG 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: 16608267
• Report Number: 3007111389-2023-00051
• Device Sequence Number: 17679476
• Product Code: LOM
• UDI-Device Identifier: 10758750001064
• UDI-Public: 10758750001064
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 03/23/2023

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: 10/26/2022
• Device Model Number: 6801322
• Device Catalogue Number: 6801322
• Device Lot Number: 9000
• 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: 02/24/2023
• Initial Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• 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