MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CREA SLIDES; IN-VITRO DIAGNOSTIC

Catalog Number 6802584

Device Problem Low Test Results (2458)

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

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros creatinine (crea) results were obtained from a single patient sample when tested using vitros crea reagent on a vitros 250 chemistry system.The assignable cause of the event was likely a sample related issue.The patient was treated with an unknown concentration of metamizol, which is listed in the vitros crea instructions for use (ifu) as a substance that interferes and can cause a negative bias.The customer did not provide the type of collection device used, any information in regard to pre-analytical sample handling, or any information on the appearance of the sample.It is unknown if the customer is adhering to the sample collection device manufacturer¿s recommendations for sample centrifugation.It cannot be confirmed or ruled out if pre-analytical sample handling contributed to the event.A within run precision test was not processed on the analyzer, however the analyzer is not a likely cause of the event as, per the customer, no other assays were affected, and the issue was isolated to this single patient sample result.Historical quality control results were not provided by the customer; however a reagent issue is not the likely cause as the customer indicated the issue was only with this single patient sample and had no further complaints in regards to vitros crea.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros crea slide lot 1530-3497-3380 the customer has had no further complaints with vitros crea or any other assays and declined further troubleshooting with ortho.

Event Description

A customer obtained lower than expected vitros creatinine (crea) results from a single patient sample when tested using vitros crea reagent on a vitros 250 chemistry system.Patient sample crea results of 0.20, 0.20, 0.30 mg/dl vs.The expected result of 1.8 mg/dl.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected vitros crea results were not reported outside the laboratory.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 CHEMISTRY PRODUCTS CREA SLIDES
• 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; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9835940
• MDR Text Key: 215144281
• Report Number: 1319809-2020-00036
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/16/2020

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: 04/01/2021
• Device Catalogue Number: 6802584
• Device Lot Number: 1530-3497-3380
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2019
• 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