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

Catalog Number	6844295
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, lower than expected result was obtained from a single patient sample using vitros glucose (gluxt) slide lot 7419-0016-8376 tested on a vitros xt 7600 integrated system.The most likely assignable cause for this event could not be determined.Based on historic quality control results, there was some imprecision observed using vitros gluxt slide lot 7419-0016-8376, however, the magnitude of bias observed would not have contributed to the bias observed with the affected patient sample.Therefore, vitros gluxt slide lot 7419-0016-8376 did not likely contribute to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros gluxt slide lot 7419-0016-8376.Based on acceptable diagnostic vitros alkp within-run precision testing, the vitros xt 7600 integrated system was performing as intended and did not likely contribute to the event.Finally, improper pre-analytical sample processing cannot be ruled out as contributing to the event.It is unknown if the affected sample was centrifuged according to the sample collection device manufacturer's specifications, and it is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, lower than expected result was obtained from a single patient sample using vitros glucose (gluxt) slide lot 7419-0016-8376 tested on a vitros xt 7600 integrated system.Vitros gluxt patient sample result of <20 mg/dl vs.The repeat result of 198 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower-than-expected gluxt result predicted from the patient sample was not reported outside the laboratory, and there was no 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 (b)(4).

• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20201668
• Report Number: 1319809-2024-00071
• Device Sequence Number: 15173627
• Product Code: CGA
• UDI-Device Identifier: 10758750031795
• UDI-Public: (01)10758750031795(17)250601(11)231227(10)741900168376
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/11/2024

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: 06/01/2025
• Device Catalogue Number: 6844295
• Device Lot Number: 7419-0016-8376
• 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: 08/18/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2023
• 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