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

Model Number 1707801

Device Problem High Test Results (2457)

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

The customer reported non-reproducible, higher than expected vitros glu results were obtained from two different patient samples tested on a vitros xt7600 integrated system.Patient 1: vitros glu results of >625, >1250, 402 mg/dl vs.The expected result of 178.0 mg/dl.Patient 2: vitros glu result of >625, >1250 mg/dl vs.The expected result of 68.0 mg/dl.Biased results of the direction and magnitude observed could lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros glu patient results were not reported from the laboratory.There were no allegations of patient harm as a result of this event.This report is number two of five mdr¿s for this event.Five 3500a forms are being submitted for this event as five devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

Manufacturer Narrative

The investigation determined that non-reproducible, higher than expected vitros glu results were obtained from two different patient samples tested on a vitros xt7600 integrated system.The assignable cause for this event could not be determined.The higher than expected vitros glu results for both patient samples and the expected glu results were obtained from the same vitros glu slide cartridge.It is possible that there is a potential performance issue with some, but not all, vitros glu slides from the affected slide cartridge.Based on a review of historical quality control results, there was no indication of a performance issue at the customer site with vitros glu slide lot 0023-3233-9086.However, continual track and trending of complaints identified a slight increase in complaints for higher than expected and non-reproducible results using vitros glu slide lot 0023-3233-9086, and with vitros glu slides from coating 3233.Therefore, a vitros glu slide lot issue could not be entirely ruled out as a contributor to the event.No diagnostic within run precision testing was performed to assess the performance of the vitros xt7600 integrated system.Therefore, it is unknown if the vitros xt7600 integrated system was performing as intended and an instrument issue cannot be ruled out as a contributor to the event.Pre-analytical sample processing could not be ruled out as a contributing factor, as it is unknown if the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation and cellular debris, due to poor sample preparation, could have been present in the affected sample, although this could not be confirmed.

• Brand Name: VITROS CHEMISTRY PRODUCTS GLU 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: 17783391
• MDR Text Key: 323863012
• Report Number: 0001319809-2023-00118
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1707801
• Device Catalogue Number: 1707801
• Device Lot Number: 0023-3233-9086
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1