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

Catalog Number 6802584

Device Problem High Test Results (2457)

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

Event Date 09/15/2021

Event Type  malfunction  

Event Description

The investigation determined that higher than expected vitros creatinine (crea) results were obtained from a single patient sample tested on two different vitros 5600 integrated systems.The results were higher than expected compared to the result obtained from a second sample collected from the same patient.Patient sample 1 crea results of 2.93 and 2.99 mg/dl vs.The sample 2 result of 0.74 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros crea result of 2.93 mg/dl was reported outside of the laboratory, however the result was questioned by a physician, who believed the result of 0.74 mg/dl was correct.A corrected report was not issued.It is unknown if any treatment was stopped, started, or altered based on the reported vitros crea result, however there was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

Manufacturer Narrative

The investigation determined that higher than expected vitros creatinine (crea) results were obtained from a single patient sample tested on two different vitros 5600 integrated systems.The results were higher than expected compared to the result obtained from a second sample collected from the same patient.The assignable cause of the event is a sample related issue.The sample handling protocol is unknown, and sample 1 had increased hemolysis on both runs, while sample 2 showed expected hemolysis.Therefore, an issue with pre-analytical sample handling cannot be ruled out as a contributor.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.It is also unknown what medications the patient was currently taking, therefore an issue from an unknown sample interferent cannot be ruled out as a contributor.Historical vitros crea quality control results were not as expected, indicating a possible issue with vitros crea slide lot 1515-3481-0363.However, continual tracking and trending does not indicate a systemic issue with vitros crea lot 1515-3481-0363.Precision performance testing used to assess performance of the vitros 5600 systems was within acceptable guidelines, indicating that both vitros 5600 integrated systems were performing as intended.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 12638580
• MDR Text Key: 281677836
• Report Number: 1319809-2021-00149
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: 6802584
• Device Lot Number: 1515-3481-0363
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1