MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS NA+ SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number 8379034

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2024

Event Type  malfunction  

Event Description

A distributor contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) on behalf of a customer to report higher than expected vitros sodium (na+) results were obtained from vitros performance verifier (pv) i q1174 using vitros na+ slide lot 4212-1097-6151 on a vitros 5600 integrated system.Vitros pv q1174 na+ results of 138.2 and 142.5 mmol/l vs.The expected result of 115.2 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The affected samples were non-patient quality control fluids.There was no allegation of of patient harm as a result of this event.This report is number one of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

Manufacturer Narrative

The investigation determined that higher than expected vitros sodium (na+) results were obtained from vitros performance verifier (pv) i q1174 using vitros na+ slide lot 4212-1097-6151 on a vitros 5600 integrated system.The assignable cause of the event could not be determined.Pre-analytical sample mix-up was a potential cause of the event; however, the customer could not confirm it occurred.Historical quality control results indicated that within-lab imprecision was present prior to the event, therefore, a performance issue with vitros na+ slide lot 4212-1097-6151 cannot be ruled out as contributing to the event.Further investigation was not possible as the inventory of the slide lot was depleted at the site.However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros na+ slide lot 4212-1097-6151.Acceptable vitros na+ performance was obtained with an alternate vitros na+ slide lot 4217-1103-9397.A performance issue with the vitros 5600 integrated system did not likely contribute to the event as within-run vitros na+ precision testing using vitros na+ slide lot 4217-1103-9397 was acceptable, without performing any actions to optimize the instrument.

• Brand Name: VITROS CHEMISTRY PRODUCTS NA+ SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18896952
• MDR Text Key: 337780944
• Report Number: 1319809-2024-00031
• Device Sequence Number: 1
• Product Code: JGS
• UDI-Device Identifier: 10758750004812
• UDI-Public: 10758750004812
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8379034
• Device Lot Number: 4212-1097-6151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1