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

Catalog Number 6802584

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that non-reproducible lower than expected vitros creatinine (crea) results were obtained when processing a patient sample on a vitros 3400 chemistry system when compared with the repeat result.The investigation could not determine a definitive assignable cause of the event.The customer did not provide any information regarding which quality control fluid is used for daily testing to evaluate the performance of vitros crea lot 1526-3529-5240.An issue with vitros crea lot 1526-3529-5240 cannot be entirely ruled out.However, the customer did indicate that quality control results were within range for all vitros microslide assays impacted on 20 february 2024.Although no information was provided to assess the performance of vitros crea lot 1526-3529-5240, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros crea lot 1526-3529-5240.Diagnostic within run precision tests do not indicate an issue with the performance of vitros 3450 chemistry as a cause of the event.It is unknown if the customer is following the collection device manufacturer's centrifugation recommendations when processing the patient sample.Therefore, a sample related issue may have contributed to the event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report non-reproducible lower than expected vitros creatinine (crea) results were obtained when processing a patient sample on a vitros 3400 chemistry system when compared with the repeat result.Vitros crea results 0.71 and 0.92 mg/dl versus the repeat vitros crea result of 1.92 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros crea results were not reported outside the laboratory.No allegation of patient harm was made due to the event on 20 february 2024.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).

• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18950268
• MDR Text Key: 338558241
• Report Number: 1319809-2024-00034
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 10758750002849
• UDI-Public: 10758750002849
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: 6802584
• Device Lot Number: 1526-3529-5240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1