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

Catalog Number 6844295

Device Problem High Test Results (2457)

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

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a higher than expected glucose csf (glu-ca) result was obtained from a vitros liquid performance verifier (lpv) using vitros xt chemistry products glu-ca slides lot 7418-0015-1820 on a vitros xt 7600 integrated system.A definitive assignable cause of the event could not be determined.As there was not enough historical qc results to adequately evaluate the performance of the reagent, an issue related to vitros xt glu-ca slides lot 7418-0015-1820 cannot be ruled out as a contributor of the event.The results of vitros alkp diagnostic precision testing performed on the vitros xt 7600 integrated system were within acceptable guidelines indicating that an instrument related issue was not likely a contributor of the event.However, as the precision testing was not performed around the timeframe of the event, an instrument related issue cannot be entirely ruled out as a contributing factor of the event.As the customer used an alternate set of vitros lpv fluids to obtain acceptable results, an issue related to the performance of vitros lpv i lot w9322 cannot be ruled out as a contributor of the event.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros xt glu-ca slides lot 7418-0015-1820.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected glucose csf result was obtained from a vitros liquid performance verifier (lpv) using vitros xt chemistry products glu-ca slides lot 7418-0015-1820 on a vitros xt 7600 integrated system.Vitros lpv i lot w9322 vitros glucsf result of 45.7 mg/dl vs an expected result of 39.4 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 higher than expected vitros glucsf result was from a non-patient fluid and was not reported from the laboratory.There has been no reported allegation 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 603545.

• Brand Name: VITROS XT CHEMISTRY PRODUCTS GLU-CA 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: 17948493
• MDR Text Key: 325806573
• Report Number: 0001319809-2023-00124
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 10758750031795
• UDI-Public: 10758750031795
• 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: 10/12/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 6844295
• Device Lot Number: 7418-0015-1820
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1