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

Model Number	6844295
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros cerebral spinal fluid (csf) glucose (glu) result was obtained from a single college of american proficiency (cap) survey sample suing vitros glu xt reagent lot 7417-0014-4811 processed on a vitros xt7600 integrated system.The assignable cause for this event is unknown.Historical vitros glucsf quality control results showed imprecision at a similar concentration as the affected cap proficiency sample, indicating that the vitros glu xt lot 7417-0014-4811 was not performing as expected at this concentration.However, continual tracking and trending of complaints does not indicate a systemic issue with vitros gluy xt lot 7417-0014-4811.The customer indicated that the original sample report to cap was sent in error.The customer stated that he believed the laboratory technician that processed the samples had run them under the wrong body fluid, however a review of e-connectivity showed that the results obtained were under the correct body fluid of csf.It is unknown if there was another sample handling error made by the customer.An issue with improper sample handling cannot be ruled out as a contributor to the event.Precision testing used to assess the performance of the vitros xt7600 integrated system was not performed at the time of the event, therefore, an instrument related issue cannot be completely ruled out.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros cerebral spinal fluid (csf) glucose (glu) result was obtained from a single college of american proficiency (cap) survey sample using vitros glu xt reagent lot 7417-0014-4811 processed on a vitros xt7600 integrated system.Glu csf cap sample m-03 result of 283.0 mg/dl vs.The expected result of 36.6 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 customer made no indication that vitros csf glu patient results have been questioned by clinicians.There were no reported allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 602240.

• Brand Name: VITROS XT CHEMISTRY PRODUCTS GLU-CA SLIDES
• Common Device Name: 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: 17118720
• Report Number: 0001319809-2023-00046
• Device Sequence Number: 12520674
• Product Code: CGA
• UDI-Device Identifier: 10758750031795
• UDI-Public: 10758750031795
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: 6844295
• Device Catalogue Number: 6844295
• Device Lot Number: 7417-0014-4811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown