MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HAV IGM REAGENT PACK; IN-VITRO DIAGNOSTIC

Catalog Number 6801812

Device Problems False Positive Result (1227); Incorrect Or Inadequate Test Results (2456)

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

Event Date 02/18/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a (b)(6) vitros anti hav igm result was obtained from a single patient sample tested on a vitros 3600 system.The definitive assignable cause could not be determined.No precision testing was performed to verify the performance of the vitros instrument at the time of the event and therefore an instrument issue cannot be entirely ruled out as contributing to the event.No historical quality control results were provided for the event so a vitros anti hav igm reagent performance issue also cannot be ruled out as contributing to the event.In addition, an unknown sample interferent, method to method difference or improper sample processing (sample centrifugation) cannot be ruled out as contributing factors.

Event Description

The customer reported that a (b)(6) vitros anti hav igm result was obtained from a single patient sample using vitros anti hav igm reagent, lot 4730 on a vitros 3600 immunodiagnostic system.(b)(6).Biased results of the magnitude and direction observed may lead to inappropriate physician action.The (b)(6) result for the patient was not reported outside of the laboratory and there was no allegation of patient harm as a result of this event.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HAV IGM 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: 6457944
• MDR Text Key: 72096851
• Report Number: 3007111389-2017-00040
• Device Sequence Number: 1
• Product Code: LOL
• 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: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2017
• Device Catalogue Number: 6801812
• Device Lot Number: 4730
• Other Device ID Number: 10758750001415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2016
• 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