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

Catalog Number	1707801
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An ortho clinical diagnostics (ortho) field application specialist (fas) contacted the ortho technical solutions center (tsc) on behalf of a customer to report a non-reproducible, lower than expected glucose (glu) result was obtained from a single patient sample processed using vitros chemistry products glu slides lot 0036-3248-5953 on a vitros 5600 integrated system.Patient sample result of 2.42 mmol/l vs an expected result of 12.88 mmol/l 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 glu result was not reported from the laboratory.There have been 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 (b)(4).
Additional Manufacturer Narrative
The investigation has determined that a non-reproducible, lower than expected glucose (glu) result was obtained from a single patient sample processed using vitros chemistry products glu slides lot 0036-3248-5953 on a vitros 5600 integrated system.A definitive assignable cause of the event could not be determined.Based on historical quality control results, a vitros glu lot 0036-3248-5953 performance issue is not likely a contributor to the event.However, an individual slide related issue cannot be entirely ruled out as a contributing factor.The results of vitros glu precision testing performed on the vitros 5600 integrated system were within ortho acceptable guidelines.In addition, the expected result was reproduced by an ortho field application specialist without any change to the vitros 5600 integrated system.Therefore, an instrument related issue is not a likely contributing factor of the event.Pre-analytical sample processing could not be ruled out as a contributing factor as it was unknown if the customer was following the sample collection device manufacturer's recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros glu reagent lot 0036-3248-5953.

• Brand Name: VITROS CHEMISTRY PRODUCTS GLU 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21761631
• Report Number: 1319809-2025-00048
• Device Sequence Number: 8676361
• Product Code: CGA
• UDI-Device Identifier: 10758750009572
• UDI-Public: (01)10758750009572(17)260301(11)240904(10)003632485953
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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: 03/01/2026
• Device Catalogue Number: 1707801
• Device Lot Number: 0036-3248-5953
• 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: 03/21/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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