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

Model Number 6802584

Device Problem Low Test Results (2458)

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

Event Date 01/26/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected vitros crea results were obtained from a non-vitros biorad lot 89700 control fluid using vitros chemistry products crea slides lot 1545-3526-1416 on a vitros 5600 integrated system.The assignable cause cannot be determined with the information provided.An issue with the vitros 5600 integrated system cannot be ruled out as a contributing factor.Vitros crea diagnostic precision tests were run using both non-vitros biorad and ortho pv fluids, and while the precision tests were just within ortho acceptable guidelines, the individual results showed inaccuracy when compared to the expected results, indicating that an issue with the vitros 5600 integrated system is a possible contributor to the events.The ortho ls and ortho fe are continuing to work on the 5600 system.Historical qc was not as expected for vitros crea slide lot 1545-3526-1416.Additionally, results run on an alternate lot of vitros crea for troubleshooting purposes were also outside expectation.It is unlikely that two lots of vitros crea reagent are producing unexpected results at the same time due to an assay issue, therefore an issue with vitros crea lot 1545-3526-1416 is not a likely contributor to the event.However, it is possible that the vitros crea cartridge in use that produced the lower than expected results is a contributor to the event, as this was the only cartridge that produced results that breached phs, and no results obtained on this cartridge were within expectation for either level of qc.Additionally, continual tracking and tending of complaint data does not indicate that there is a systemic quality issue with vitros crea reagent lot 1545-3526-1416.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros crea results were obtained from a non-vitros biorad lot 89700 control fluid using vitros chemistry products crea slides lot 1545-3526-1416 on a vitros 5600 integrated system.Vitros crea biorad lot 89700 results of 1.39, 1.49, 1.46, 1.46, 1.43, and 1.49 mg/dl versus the expected result of 1.87 mg/dl 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 crea results occurred on a non-vitros control fluid.There have been no allegations of patient harm as a result of this event, however the investigation cannot conclude that patient sample results had not been affected or would not be affected if the event were to recur undetected.This report is number two of six mdr¿s for this event.Six 3500a forms are being submitted for this event as six devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number 400100630 and reportability assessment 600962.

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16428049
• MDR Text Key: 310240496
• Report Number: 0001319809-2023-00006
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 10758750002849
• UDI-Public: 10758750002849
• Combination Product (y/n): N
• Reporter Country Code: PM
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Model Number: 6802584
• Device Catalogue Number: 6802584
• Device Lot Number: 1545-3526-1416
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1