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

Catalog Number 6801325

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that (b)(6) results were obtained for a single patient processed using vitros anti-hcv reagent on a vitros 3600 immunodiagnostic system (s/n (b)(4)).The assignable cause is unknown.A calibration issue, sample storage issue, or pre-analytical sample handling could not be ruled out as contributing factors.There is no indication that the instrument and/or the reagent were not performing as expected as quality control fluid results were reported as acceptable.

Event Description

The customer observed (b)(6) results obtained for a single patient, processed using vitros anti-hcv reagent on a vitros 3600 immunodiagnostic system.Vitros (b)(6) results (b)(6) ((b)(6)) versus expected results of (b)(6) ((b)(6)).Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The discordant negative results were not reported from the laboratory.Ortho was not made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics (ortho) inc.Complaint number (b)(4) / qerts record id (b)(4).This report is number one of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 7453943
• MDR Text Key: 107104365
• Report Number: 3007111389-2018-00056
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 6801325
• Device Lot Number: 4200
• Other Device ID Number: 10758750001095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2017
• 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