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	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An ortho clinical diagnostics quality engineer reviewed test data for an investigation for increased quality control calibration failure for vitros anti-hbs (ahbs) reagent lot 8940.The assignable cause for the unexpected positive vitros anti-hbs result could not be determined.The investigative test event produced a valid calibration and acceptable quality control results indicating acceptable vitros anti-hbs reagent lot 8940 performance.However, ortho has opened a current investigation for investigation for increased calibration failures and both higher and lower than expected quality control results for multiple vitros anti-hbs reagent lots.No performance precision testing that would verify the vitros eci immunodiagnostic system was performing as intended was performed, therefore, it was not possible to rule out the vitros eci immunodiagnostic system as contributing to the event.Ortho has a current investigation for increased calibration failures and higher and lower than expected quality control results.
Event or Problem Description
A ortho clinical diagnostics (ortho) quality engineer reported increased quality control calibration failure results for vitros anti-hbs (ahbs) reagent lot 8940.Vitros anti-hbs kit lot 8940 was tested and found the reagent lot had generated one false positive anti-hbs result for sample ((b)(6)) considered to be truly anti-hbs negative vitros anti-hbs lot 8940 sample (b)(6) result 13.5 miu/ml (reactive / positive) vs.Expected result of negative.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The unexpected positive ahbs result occurred on a known negative panel sample used for internal testing and there is no report of affected patient samples.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) nonconformance 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: 18003116
• Report Number: 3007111389-2023-00186
• Device Sequence Number: 7604067
• Product Code: LOM
• UDI-Device Identifier: 10758750001682
• UDI-Public: 10758750001682
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2023

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: Other
• Device Expiration Date: 01/13/2024
• Device Catalogue Number: 6801925
• Device Lot Number: 8940
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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