MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM; CHEMISTRY ANALYZER

Model Number	1922814
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2023
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 tsh results were obtained from a single level of non-vitros thermofisher mas omni-immune control, lot 2302 tested on a vitros eciq immunodiagnostic system.Mas level 1 control fluid vitros tsh results of 0.079, 0.044, 0.075 and 0.038 miu/l vs.The baseline mean value of 0.135 miu/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected results were obtained from non-patient quality control samples and there was no allegation of patient harm as a result of the event.However, the investigation could not rule out that patient samples would not be affected if the event were to recur undetected.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 601121.
Additional Manufacturer Narrative
The investigation concluded that lower than expected vitros tsh results were obtained from a single level of non-vitros thermofisher mas omni-immune control, lot 2302 tested on a vitros eciq immunodiagnostic system.The most likely assignable cause is instrument related.An ortho field engineer (fe) went on site and discovered the connections to the signal reagent (sr) dispense probes were very loose.The ortho fe replaced the sr dispense probes and verified all incubator, sr and well wash alignments.Once the service actions were completed, after the service actions were performed, acceptable vitros tsh performance was obtained.

• Brand Name: VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM
• Common Device Name: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16548645
• Report Number: 0001319681-2023-00016
• Device Sequence Number: 6042656
• Product Code: KHO
• UDI-Device Identifier: 10758750000272
• UDI-Public: 10758750000272
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/15/2023

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 Model Number: 1922814
• Device Catalogue Number: 1922814
• 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: 02/16/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2022
• 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