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

Model Number 8157596

Device Problem Low Test Results (2458)

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros potassium (k+) results were obtained from vitros performance verifier ii (pv ii) fluid using vitros k+ reagent lot 4102-1126-7830 on a vitros 350 chemistry system.The assignable cause of the unexpected vitros k+ results is unknown.It is possible that the age of the reagent cartridge used for the precision testing contributed to the event, as the customer indicated that they used a cartridge that was previously on board for the precision testing, although this could not be confirmed.Historical vitros k+ lot 4102-1126-7830 quality control was within expectation leading up to the event, indicating that the reagent lot was performing as expected leading up to the event.An issue with the vitros 350 chemistry system was not a likely contributor to the event as a within run vitros k+ precision results obtained using an alternate lot of vitros k+ were within ortho acceptable guidelines.In addition, a diagnostic within run precision test was processed using vitros na+ slides and the results were within ortho acceptable guidelines.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros k+ slides lot 4102-1126-7830.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros potassium (k+) results were obtained from vitros performance verifier ii (pv ii) fluid using vitros k+ reagent lot 4102-1126-7830 on a vitros 350 chemistry system.Vitros k+ lot 4102-1126-7830 vitros pv ii fluid lot p9966 results of 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, and 2.70 versus the expected result of 5.72 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 lower than expected vitros k+ results were obtained on a vitros performance verifier ii fluid.There was no report of affected patient samples.There was no allegation of patient harm as a result of this event.This report is number eight of fifteen mdrs for this event.Fifteen 3500a forms are being submitted for this event as fifteen 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 K+ SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; 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: 18626634
• MDR Text Key: 334389061
• Report Number: 1319809-2024-00013
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: 10758750010233
• UDI-Public: 10758750010233
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8157596
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1126-7830
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1