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 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that higher than expected sodium (na+) results were obtained from a non-vitros biorad quality control fluid and a vitros performance verifier processed using vitros chemistry products na+ slides lot 4225-1110-2372 on a vitros xt 7600 integrated system.The investigation could not determine a definitive assignable cause of the event.Based on historical quality control results from vitros performance verifiers, a vitros na+ lot 4225-1110-2372 performance issue cannot be ruled out as a contributor of the events.The results of diagnostic precision testing performed on the vitros xt 7600 system were within ortho acceptable guidelines, however, the testing was not performed around the timeframe of the events.Additionally, historical quality control results from vitros pv fluids were imprecise.Therefore, an instrument related issue cannot be ruled out as a contributing factor of the events.A sample related issue can be ruled out as a contributing factor of the event as the ortho ls confirmed that the customer was following proper fluid preparing and handling protocol.Additionally, the customer confirmed that the higher than expected results were not due to sample fluid mix-up.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros na+ lot 4225-1110-2372.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected sodium (na+) results were obtained from a non-vitros biorad quality control fluid and a vitros performance verifier processed using vitros chemistry products na+ slides lot 4225-1110-2372 on a vitros xt 7600 integrated system.Biorad lot 89710 level 2 results of 136.4 and 136.6 mmol/l vs an expected result of 124.0 mmol/l vitros pv i lot q1174 result of 149.8 mmol/l vs an expected result of 117.1 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 higher than expected vitros na+ results were obtained from quality control fluids and were not reported from the laboratory.The customer stated that no patient sample results have been questioned.There have been no reported allegations of patient harm as a result of this event.This report is number one of three mdrs for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• 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: 18830599
• MDR Text Key: 337748355
• Report Number: 1319809-2024-00026
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• 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: 4225-1110-2372
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1