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

Catalog Number 6801325

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

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

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant, (b)(6) vitros ahcv results were obtained from two samples from the same patient when tested on a vitros 5600 integrated system.The results were discordant compared to (b)(6) results obtained from non-vitros methods.A definitive assignable cause of the event was not established.A sample interferent that affects the vitros ahcv reagent assay cannot be ruled out as a contributor to the event, as no testing to rule out the presence of a sample interferent was conducted.A vitros ahcv lot 4511 reagent issue is an unlikely contributor to the event, as historical vitros ahcv results were within acceptable guidelines.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ahcv reagent lot 4511.An instrument issue cannot be ruled out as a contributor to the event, as no precision testing was conducted on the vitros 5600 integrated system to verify its performance.In addition, pre-analytical sample processing could not be ruled out as a contributing factor as the customer is not following the sample collection device manufacture¿s recommendation for sample centrifugation.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.

Event Description

A customer contacted the ortho (ortho clinical diagnostics) technical solutions centre (tsc) to report discordant, (b)(6) vitros anti-hcv (ahcv) results when testing two samples from the same patient on a vitros 5600 integrated system.The results were discordant compared to (b)(6) results obtained from a non-vitros (roche) method.Vitros ahcv results of (b)(6) versus the expected results of (b)(6).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The (b)(6) vitros ahcv results were not reported from the laboratory.The customer believed the non-vitros ahcv results of (b)(6) as truth for the patient.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.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK
• Type of Device: IN VITRO DIAGNOSTICS
• 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: 9365635
• MDR Text Key: 220566471
• Report Number: 3007111389-2019-00188
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Reporter Country Code: BG
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2019
• Device Catalogue Number: 6801325
• Device Lot Number: 4511
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2019
• 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