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

Catalog Number 6801925

Device Problem False Positive Result (1227)

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

Event Date 09/08/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that discordant reactive vitros (b)(6)results were obtained from two different samples from a single patient using vitros immunodiagnostic products (b)(6) reagent lot 3310 in combination with a vitros 3600 immunodiagnostic system.The results were discordant when compared to (b)(6) results obtained from two different non-vitros methods.A definitive assignable cause for the discordant vitros results could not be determined with the information provided.Based on historical quality control (qc) results, a vitros (b)(6) reagent performance issue is not a likely contributor to the event as all qc fluid results were within expectations.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros (b)(6) reagent lot 3310.Precision testing was not conducted on the vitros 3600 immunodiagnostic system therefore, an instrument related issue could not be entirely ruled out as a contributor to the event.However, there is no indication of an instrument malfunction.Additionally, pre-analytical sample processing cannot be ruled out as a contributing factor.The customer was not following the sample collection device manufacturer¿s recommended centrifugation protocol.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.Furthermore, the presence of an unknown sample interferent cannot be completely ruled out as the cause of the discordant reactive vitros results as no sample volume remained available to test using blocking tubes.

Event Description

A customer reported two false (b)(6) vitros (b)(6) patient sample results from a single patient using vitros immunodiagnostic products (b)(6)reagent on a vitros 3600 immunodiagnostic system.The results were discordant when compared to negative results obtained from two different non-vitros methods.Patient sample results of > 1000 and > 1000 miu/ml (reactive) versus the expected result of negative.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected reactive vitros (b)(6) results were not reported from the laboratory and 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-HBS 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: 9218869
• MDR Text Key: 220781320
• Report Number: 3007111389-2019-00163
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/22/2019

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: 11/06/2019
• Device Catalogue Number: 6801925
• Device Lot Number: 3310
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• 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