MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN-VITRO DIAGNOSTICS

Model Number	1882208
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
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 lactate (lac) results were obtained from college of american pathologists (cap) proficiency samples and a non-vitros biorad quality control fluid using vitros chemistry products lac slides lot 3534-0117-8020 on a vitros 5600 integrated system.Cap sample (b)(6) result of 7.4 mmol/l vs an expected result of 8.90 mmol/l cap sample (b)(6) result of 3.0 mmol/l vs an expected result of 3.83 mmol/l cap sample (b)(6) result of 6.1 mmol/l vs an expected result of 7.56 mmol/l cap sample (b)(6) result of 2.6 mmol/l vs an expected result of 3.27 mmol/l biorad lot 45910 level 3 results of 4.43, 4.49, 4.44, 4.41, 4.40, 4.47, 4.37, 4.36, 4.39, 4.58, 4.40, 4.40, 4.37, 4.46, 4.41, 4.36, 4.42, 4.48, 4.42, 4.61, 4.37, 4.36 and 4.45 mmol/l vs an expected result of 5.45 mmol/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 vitros lac results were obtained from proficiency samples and a non-vitros quality control fluid.The customer did not inform ortho that any erroneous patient results were obtained or reported from the laboratory.Ortho has not been made aware of any 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).
Additional Manufacturer Narrative
The investigation has determined that lower than expected lactate (lac) results were obtained from college of american pathologists (cap) proficiency samples and a non-vitros biorad quality control fluid using vitros chemistry products lac slides lot 3534-0117-8020 on a vitros 5600 integrated system.The assignable cause of the events is a suboptimal calibration.The calibration parameters for the lactate calibration in use at the time of the events was determined to be atypical when compared to the expected database values.The quality control results obtained after the calibration event were not acceptable.In addition, the lower than expected proficiency sample results were obtained using the atypical calibration parameters.The cause of the atypical calibration is unknown.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros lac reagent lot 3534-0117-8020.No further investigation was performed on vitros lactate lot 3534-0117-8020 as the customer had moved to an alternate lactate lot by the time they contacted the ortho tsc.

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
• 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.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17039130
• Report Number: 0001319808-2023-00010
• Device Sequence Number: 17895550
• Product Code: JIX
• UDI-Device Identifier: 10758750000166
• UDI-Public: 10758750000166
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/31/2023

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: 05/30/2024
• Device Model Number: 1882208
• Device Catalogue Number: 1882208
• Device Lot Number: 0142
• 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: 05/04/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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