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

Catalog Number 6801322

Device Problem Incorrect Measurement (1383)

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

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that (b)(6) results were obtained from a single patient sample while using two vitros hbsag reagent lots across three different vitros 5600 integrated systems.The most likely assignable cause was a sample related issue as the results were reproducible across both vitros reagent lots and across all three vitros instruments.As no information was provided, pre-analytical sample handling cannot be ruled out as a contributing factor.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.In addition, the presence of (b)(6) that is not detected by the vitros hbsag assay cannot be ruled out as contributing to the event.There was no evidence to suggest that the vitros hbsag reagents or vitros 5600 instruments malfunctioned.

Event Description

The customer obtained (b)(6) results from a single patient sample tested on two different vitros hbsag reagent lots when tested across three different vitros 5600 integrated systems when compared to results from a non-vitros method: reagent 7870.Patient 1: (b)(6) results.Reagent 7930.Patient 1: (b)(6) results.Biased results of the magnitude and direction observed may lead to inappropriate physician action if undetected.The negative discordant results were not reported outside of the laboratory and there was no report of patient harm as a result of this event.This report is number two of two 3500a forms filed for this event, as two devices were affected.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG 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: 5967035
• MDR Text Key: 55693307
• Report Number: 3007111389-2016-00180
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2017
• Device Catalogue Number: 6801322
• Device Lot Number: 7930
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1