MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK; IN VITRO DIGANOSTICS

Catalog Number 6801428

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant, false reactive vitros (b)(6) results were obtained from multiple patient samples when tested on a vitros 5600 integrated system and three vitros 3600 immunodiagnostic systems.The results were discordant compared to non-reactive (b)(6) results obtained from an abbott method.A definitive cause of the discordant, false reactive vitros (b)(6) results was not established.Method to method differences between the vitros (b)(6) reagent and the abbott (b)(6) assay cannot be ruled out as a contributor to the event.It is possible that the vitros (b)(6) reagent is a less sensitive method for testing for antibodies to the (b)(6) core antigen, owing to the higher vitros (b)(6) results that breach the ifu interpretation for a positive result.A vitros (b)(6) reagent issue is an unlikely contributor to the event, as quality control results before and around the time of the event were within acceptable guidelines on all four vitros instruments.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros (b)(6) lot 2420 and vitros (b)(6) lot 2430.There was no indication of a vitros instrument malfunction however diagnostic within run precision testing was not completed to evaluate the performance.Therefore, a vitros 5600 or 3600 system issue cannot be entirely ruled out.Pre-analytical sample processing could not be ruled out as contributing to this event, as it is unknown if the patient samples were prepared in accordance with the tube manufacturer¿s recommendations.Turbidity in patient samples can affect vitros (b)(6) results.However, turbidity can be ruled out as a cause of the event, as the turbidity index for each patient sample did not indicate that samples were turbid.Additionally, non-specific antibody interference cannot be ruled out as a contributor to the event.Vitros (b)(6) testing could not be carried out using nabts as there was no patient sample remaining.It is possible that an unknown interferent was causing false reactive vitros (b)(6) results, although this could not be determined.The reactive vitros (b)(6) 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.

Event Description

On 12 september 2019, a customer contacted the ortho (ortho clinical diagnostics) technical solutions centre (tsc) to report discordant, reactive vitros (b)(6) results when testing multiple patient samples on a vitros 5600 integrated system and three vitros 3600 immunodiagnostic systems.The result were discordant when compared to the non-reactive results tested on an abbott architect system.The first event occurred (b)(6) 2019.Vitros (b)(6) lot 2420 results: patient 1 vitros (b)(6) result of 0.18 s/c (reactive) vs the abbott result of non-reactive, patient 6 vitros (b)(6) result of 0.84 s/c (reactive) vs the abbott result of non-reactive.Vitros (b)(6) lot 2430 results: patient 2 vitros (b)(6) result of 0.96 s/c (reactive) vs the abbott result of non-reactive, patient 3 vitros (b)(6) result of 0.96 s/c (reactive) vs the abbott result of non-reactive, patient 4 vitros (b)(6) result of 0.93 s/c (reactive) vs the abbott result of non-reactive, patient 5 vitros (b)(6) result of 0.95 s/c (reactive) vs the abbott result of non-reactive, patient 7 vitros (b)(6) result of 0.33 s/c (reactive) vs the abbott result of non-reactive, patient 8 vitros (b)(6) result of 0.77 s/c (reactive) vs the abbott result of non-reactive, patient 9 vitros (b)(6) result of 0.55 s/c (reactive) vs the abbott result of non-reactive, patient 10 vitros (b)(6) result of 0.90 s/c (reactive) vs the abbott result of non-reactive, patient 11 vitros (b)(6) result of 0.95 s/c (reactive) vs the abbott result of non-reactive, patient 13 vitros (b)(6) result of 0.95 s/c (reactive) vs the abbott result of non-reactive, patient 14 vitros (b)(6) result of 0.70 s/c (reactive) vs the abbott result of non-reactive, patient 16 vitros (b)(6) result of 0.98 s/c (reactive) vs the abbott result of non-reactive.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 results were obtained on multiple different patient samples.The results were not reported outside of the laboratory and there was no allegation of patient harm.This report is number 9 of 10 mdr¿s for this event.Ten (10) 3500a forms are being submitted for this event as 10 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK
• Type of Device: IN VITRO DIGANOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9181380
• MDR Text Key: 219303113
• Report Number: 3007111389-2019-00158
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2020
• Device Catalogue Number: 6801428
• Device Lot Number: 2430
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1