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

Catalog Number	6801325
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that false non-reactive results were obtained when a level 2 (reactive) vitros ahcv control lot 1520 was processed using vitros ahcv lot 0985 across two vitros xt7600 integrated systems.The assignable cause of the event cannot be determined.A vitros ahcv lot 0985 regent issue cannot be ruled out as a contributor to the event as the false non-reactive results were isolated to results from vitros ahcv lot 0985 reagent testing and acceptable results were later obtained when customer processed vitros ahcv controls (lot 1550) on an alternate lot of reagent, lot 1080.However, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ahcv lot 0985.No diagnostic precision testing was performed on date the false non-reactive results were obtained, therefore instrument related issues cannot be ruled out as a contributor to the event.Improper handling of the vitros ahcv control cannot be ruled out as a contributor event as no information was requested in relation to the handling of the controls on the date of the event.In addition, the customer was using an adjustable pipette for control reconstitution and the ortho tsc recommended the customer use a glass volumetric pipette.Furthermore, it is possible there was an issue with the vial of the level 2 vitros ahcv control lot 1520 the false negative results were obtained, however, this could not be confirmed.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report false non-reactive results were obtained when a level 2 (reactive) vitros ahcv control (lot 1520) was processed using vitros ahcv lot 0985 across two vitros xt7600 integrated systems.Vitros xt7600 integrated system ((b)(6) - j1) level 2 (reactive) control results of 0.64, 0.61, 0.63, 0.62, 0.82, 0.81, 0.73, 0.69, 0.67 and 0.67 s/c (non- reactive) versus the expected results of reactive (?1.00 s/c) vitros xt7600 integrated system ((b)(6) - j2) level 2 (reactive) control results of 0.62, 0.59, 0.57, 0.54, 0.53, 0.49, 0.48, 0.47, 0.47 and 0.47 s/c (non-reactive) versus the expected results of reactive (?1.00 s/c) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The non-reactive vitros ahcv results were obtained when the customer was processing a non-patient fluid.There has been no allegation of patient harm as a result of this 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 ANTI-HCV 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: 20240813
• Report Number: 3007111389-2024-00186
• Device Sequence Number: 8667077
• Product Code: MZO
• UDI-Device Identifier: 10758750001095
• UDI-Public: (01)10758750001095(17)241006(11)240223(10)0985
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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: 10/06/2024
• Device Catalogue Number: 6801325
• Device Lot Number: 0985
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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