MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS ORTHO HCV 3.0; ASSAY, ELISA, HEPATITIS C VIRUS

Catalog Number 930750

Device Problem Chemical Problem (2893)

Patient Problem No Information (3190)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

Customer reported discrepant results on a cadaver sample when performing a comparison study between ortho hcv, lot txe665, and a competitor assay.The competitor's result was (b)(6).The ortho result was (b)(6).No confirmatory testing was performed in order to determine the accurate result.This was an isolated incident against this lot of product.A query of the world wide complaint database was performed for txe665 through 14jun2018.There were no other performance related complaint against this lot.

Event Description

Customer reported discrepant results on a cadaver sample, sample (b)(6), when performing a comparison study between ortho hcv, lot txe665, and a competitor assay.The competitor's result was (b)(6).The ortho result was (b)(6).No confirmatory testing was performed.Account pipettes and processes using the vip.Equipment maintenance is up to date.(b)(4).

• Brand Name: ORTHO HCV 3.0
• Type of Device: ASSAY, ELISA, HEPATITIS C VIRUS
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer Contact: matthew p wictome ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 7635777
• MDR Text Key: 112761164
• Report Number: 2250051-2018-00062
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/25/2018

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: 11/01/2018
• Device Catalogue Number: 930750
• Device Lot Number: TXE665
• Other Device ID Number: 10758750005277
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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