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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros nt-pro-bnp (ntbnp) results were obtained from a non-vitros (biorad) quality control fluid when tested on a vitros xt7600 integrated system.The most likely assignable cause could not be determined with the information currently available.There was no data suggesting an instrument malfunction contributed to the event, however, diagnostic within-run precision testing that would assess the performance of the vitros xt7600 system was not performed by the customer, as requested.Therefore, a transient instrument related issue cannot be completely ruled out.A vitros ntbnp lot 2590 reagent related issue cannot be completely ruled out, however, the customer processed minimal replicates of patient samples with known ntbnp concentrations and the replicate results obtained from each patient sample are consistent and there are no lower or higher than expected results obtained.In addition, when the lower than expected quality control results were removed from the historical quality control results accuracy and precision was acceptable.However, a reagent related issue cannot be completely ruled out as a vitros ntbnp within-run precision test was not performed by the customer as requested.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ntbnp reagent lot 2590.Improper sample handling protocol by the customer cannot be ruled out as contributing to the event.The customer did not provide any information concerning the sample handling protocols used when processing the biorad quality control fluids, therefore, it is unknown if the customer is using good laboratory practices when processing the quality controls.(b)(4).

Event Description

A customer obtained lower than expected vitros nt-pro-bnp (ntbnp) results from a non-vitros (biorad) quality control fluid when tested on a vitros xt7600 integrated system.Vitros ntbnp, biorad l3 result of 3885.3 and 1555.5 pg/ml versus the expected result (baseline mean) of 5319.6 pg/ml biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected vitros ntbnp results were obtained from a non-patient fluid.However, the investigation could rule out that patient samples had not or would not be affected if the event should recur undetected.Ortho was not made aware of any allegation of actual patient harm as a result of the 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: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10917271
• MDR Text Key: 225392347
• Report Number: 3007111389-2020-00192
• 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: 11/30/2020

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: 03/12/2021
• Device Catalogue Number: 6802156
• Device Lot Number: 2590
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/01/2020
• Initial Date FDA Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2020
• 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