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

Catalog Number	6842781
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer reported reproducible discordant reactive vitros hiv combo results from a patient sample from a birthing mother and a patient sample from the newborn baby when using a vitros immunodiagnostic products hiv combo (hivc) reagent with a vitros 5600 integrated system.A definitive assignable cause for the discordant reactive results could not be determined with the information provided by the customer.Reported biorad qc fluid performance indicates a vitros hiv combo lot 0710 performance issue is not a likely contributor to the event and no issues regarding accuracy or precision of the vitros assay were indicated by the customer.Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros immunodiagnostic products hiv combo lot 0710.The customer did not perform any precision testing on the vitros 5600 systems when requested, so no assessment of the instrument's performance at the time of the event was made.However, the customer gave no indication of any vitros 5600 system malfunction, patient sample results were reproducible for both the mother and the newborn baby and qc fluid performance was acceptable.Therefore, an instrument issue is not a likely contributor to the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was established that the customer was not following the sample collection device manufacture's recommendation for sample centrifugation and cellular debris, due to poor sample preparation, was likely present in the affected samples, although this could not be confirmed.The presence of a sample interferent in the blood of both the mother and newborn baby cannot be ruled out as contributing to this event.No testing was performed for the presence of a sample interferent using appropriate blocking tubes when requested.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report reproducible discordant reactive vitros hiv combo results from a patient sample from a birthing mother and a patient sample from the newborn baby when using a vitros immunodiagnostic products hiv combo (hivc) reagent with a vitros 5600 integrated system.False positive vitros hiv combo results are not a vitros potential health and safety criteria.However, as unknown treatment was administered to both the mother and the newborn baby based on the vitros results, this constitutes a potential health and safety complaint and is reportable.Mother sample results of 1.38, 1.31 and 1.38 s/c (reactive) versus the expected result of negative baby sample results of 1.91, 1.95 and 1.95 s/c(reactive) versus the expected result of negative biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, reactive vitros hivc results for the mother and the newborn baby were reported outside the laboratory.Based on the vitros results, unknown treatment was administered to both the mother and the newborn baby.However, ortho is not aware of any allegation of actual patient harm as a result of this event.This report is number two 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 2645748, 2648470 and reportability assessment 607362.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO 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: 20229684
• Report Number: 3007111389-2024-00179
• Device Sequence Number: 19715593
• Product Code: MZF
• UDI-Device Identifier: 10758750031580
• UDI-Public: (01)10758750031580(17)250319(11)240412(10)0710
• 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): 09/13/2024

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: 03/19/2025
• Device Catalogue Number: 6842781
• Device Lot Number: 0710
• 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: 08/19/2024
• Initial Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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