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

Catalog Number	8343386
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros digoxin (dgxn) and phenobarbital (phbr) results were obtained from a single level of non-vitros thermofisher mas omnicore (mas) lot ocr2406 using vitros dgxn slide lot 1932-0268-4412 and vitros phbr slide lot 2509-0098-9932, tested on a vitros xt7600 system.Mas level 3 dgxn results of 1.49, 1.03, 1.00, 1.39, 1.38, 1.04, 1.22, 1.26, 0.96, 1.10, 1.37, 1.37, 1.48, 1.28, 1.23, 1.16, 1.04, 1.48, 1.36, 1.48, 1.05, 1.14 and 1.40 ng/ml vs.An expected result of 2.02 ng/ml.Mas level 3 phbr results of 44.2, 44.8, 43.9 and 44.9 ug/ml vs.An expected result of 56.88 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The affected quality control sample was a non-patient quality control sample.The customer made no indication that patient sample results were affected and there were no reported allegations of patient harm.This report is number three of twenty seven mdr¿s for this event.Twenty seven 3500a forms are being submitted for this event as twenty seven devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4).
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros digoxin (dgxn) and phenobarbital (phbr) results were obtained from a single level of non-vitros thermofisher mas omnicore (mas) lot ocr2406 using vitros dgxn slide lot 1932-0268-4412 and vitros phbr slide lot 2509-0098-9932, tested on a vitros xt7600 system.The assignable cause of the event could not be determined.An instrument related issue did not likely contribute to the event as a diagnostic vitros crbm within-run precision test was acceptable, indicating the vitros xt7600 integrated system was performing as intended.A vitros dgxn and phbr slide issue could not be ruled out as contributing to the event.Acceptable vitros phbr performance was obtained after an additional calibration event, however, the calibration responses and parameters from which the lower than expected results were obtained appeared typical to expected responses and parameters.Acceptable vitros dgxn performance was obtained after an alternate vitros dgxn slide lot, 1932-0268-5736, was put into use.Therefore a performance issue with vitros dgxn slide lot 1932-0268-4412 cannot be ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros dgxn slide lot 1932-0268-4412 or vitros phbr slide lot 2509-0098-9932.

• Brand Name: VITROS CHEMISTRY PRODUCTS DGXN 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: 18133732
• Report Number: 0001319809-2023-00135
• Device Sequence Number: 6439715
• Product Code: LFM
• UDI-Device Identifier: 10758750004782
• UDI-Public: 10758750004782
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (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): 11/13/2023

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: 01/01/2024
• Device Catalogue Number: 8343386
• Device Lot Number: 1932-0268-4412
• 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: 10/16/2023
• Initial Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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