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

Catalog Number 6801812

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant (b)(6) vitros anti-hav igm results were obtained from two different samples from the same patient processed on a vitros 3600 immunodiagnostic system.The event was isolated to specific patient samples.The assignable cause for the discordant (b)(6) results was determined to be the presence of non-specific antibody interference present within the samples.Non-specific antibody interference is a known limitation of the vitros ahavm assay and is listed in the vitros ahavm instructions for use as such.There is no indication of a vitros anti hav igm reagent lot performance issue.

Event Description

The customer reported unexpected (b)(6) vitros ahavm results obtained from two different samples collected from the same patient using a vitros 3600 immunodiagnostic system when compared to (b)(6) vitros ahavt results.(b)(6).Biased results of the magnitude and direction observed may lead to inappropriate physician action.The customer had reported the discordant (b)(6) results obtained, however, confirmed that there were no allegations if harm as a result of the event.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM 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: 7294086
• MDR Text Key: 101147456
• Report Number: 3007111389-2018-00024
• 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: Other
• Type of Report: Initial
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2018
• Device Catalogue Number: 6801812
• Device Lot Number: 4900
• Other Device ID Number: 10758750001415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2017
• 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