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

Catalog Number	6801925
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that false positive vitros anti-hbs (ahbs) results were obtained from fifteen (15) different patient samples and discordant false positive, higher than expected quality control results were obtained when using vitros ahbs reagent lot 5070 on a vitros 3600 immunodiagnostic system.An assignable cause of the event could not be determined.Based on historical qc results, a vitros ahbs lot 5070 performance issue is not a likely contributor leading up to the event.Additionally, there is also no indication of any instrument malfunction and unexpected instrument performance is not a likely contributor to the event.However, as diagnostic within run precision testing was not performed on the instrument when requested, an instrument issue cannot be completely ruled out as contributing to the event.The most likely cause of the event is an unknown issue isolated to one vitros ahbs lot 5070 reagent pack in use at the time of the event.The vitros ahbs reagent pack that produced the discordant results was processed on more than one instrument at the customer site and all negative results processed were discordant.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ahbs reagent lot 5070.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report false positive vitros anti-hbs (ahbs) results were obtained from fifteen (15) different patient samples and discordant false positive, higher than expected quality control results were obtained when using vitros ahbs reagent lot 5070 on a vitros 3600 immunodiagnostic system.Patient 1, result of 86.8 miu/ml (positive) vs expected results of 1.18 miu/ml (negative).Patient 2, result of 63.2 miu/ml (positive) vs expected results of 0.00 miu/ml (negative).Patient 3, result of 64 miu/ml (positive) vs expected results of 0.14 miu/ml (negative).Patient 4, result of 83.8 miu/ml (positive) vs expected results of 0.01 miu/ml (negative).Patient 5, result of 90.8 miu/ml (positive) vs expected results of 0.00 miu/ml (negative).Patient 6, result of 86.5 miu/ml (positive) vs expected results of 0.00 miu/ml (negative).Patient 7, result of 92.5 miu/ml (positive) vs expected results of 0.00 miu/ml (negative).Patient 8, result of 65.8 miu/ml (positive) vs expected results of 0.00 miu/ml (negative).Patient 9, result of 72.7 miu/ml (positive) vs expected results of 0.00 miu/ml (negative).Patient 10, result of 53.9 miu/ml (positive) vs expected results of 1.58 miu/ml (negative).Patient 11, result of 88 miu/ml (positive) vs expected results of 0.24 miu/ml (negative).Patient 12, result of 89.1 miu/ml (positive) vs expected results of 0.00 miu/ml (negative).Patient 13, result of 98.1 miu/ml (positive) vs expected results of 5.81 miu/ml (borderline).Patient 14, result of 78.9 miu/ml (positive) vs expected results of 0.00 miu/ml (negative).Patient 15, result of 68.9 miu/ml (positive) vs expected results of 0.94 miu/ml (negative).Kangchesi tan qc results of 126.30, 120.40 and 126.10 miu/ml (positive) vs the expected result of <5.00 miu/ml (negative).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, false positive vitros ahbs patient sample results were reported from the laboratory.No treatment was initiated, altered, or stopped based on the reported results.The discordant false positive qc fluid results were 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 ANTI-HBS 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: 18149816
• Report Number: 3007111389-2023-00197
• Device Sequence Number: 5671210
• Product Code: LOM
• UDI-Device Identifier: 10758750001682
• UDI-Public: 10758750001682
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 11/15/2023

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: 01/28/2024
• Device Catalogue Number: 6801925
• Device Lot Number: 5070
• 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: 10/25/2023
• Initial Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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