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

Catalog Number 6802156

Device Problem Low Test Results (2458)

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

Event Date 01/12/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros nt-pro-bnp result was obtained from a non-vitros (biorad) quality control fluid when tested on a vitros 5600 integrated system.A definitive assignable cause could not be determined with the information provided.The affected result was isolated to a single vitros nt pro-bnp reagent pack.The issue with the affected reagent pack is unknown, as the pack was discarded by the customer and no further investigation was possible.Based on historical quality control results, a vitros nt pro-bnp lot 2220 performance issue is not a likely contributor to the event and there is also no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event.Additionally, continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros nt pro-bnp reagent lot 2220.Furthermore, a review of production logs for all the individual components in that reagent lot and the assembly into the finished component identified no issues with the production or assembly of the reagent lot that could point to the observed issue.

Event Description

A customer obtained lower than expected vitros nt-pro-bnp results from a non-vitros (biorad) quality control fluid when tested on a vitros 5600 integrated system.Biorad l3 quality control result of <11.1 pg/ml vs.Expected result of 5863 pg/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The customer confirmed that no patient samples were processed when the quality control fluid result was lower than expected and there was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP 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: 9665742
• MDR Text Key: 205515332
• Report Number: 3007111389-2020-00014
• Device Sequence Number: 1
• Product Code: NBC
• 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: 02/04/2020

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: 03/23/2020
• Device Catalogue Number: 6802156
• Device Lot Number: 2220
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2019
• 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