MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 32; IN-VITRO DIGNOSTICS

Model Number	6844508
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros sodium (na+) results were obtained from a single level of biorad unassayed control lot 92940 using vitros na+ slide lot 4212-1097-5923 on a vitros 5600 integrated system.The assignable cause of the event is a suboptimal calibration.The event started with a calibration event that occurred on (b)(6) 2023.The calibration slope parameter appeared atypical to expected slope parameters and post calibration quality control results were unacceptable.The cause of the suboptimal calibration has not been established.Historical quality control results obtained from vitros na+ slide lot 4212-1097-5923 using the previous calibration were within established control ranges, indicating the vitros na+ slides were performing as intended on the vitros 5600 integrated system.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros na+ slide lot 4212-1097-5923.Atypical vitros na+ results were obtained from a calibration generated using calibrator kit lot 3232.Therefore, a performance issue with the calibrator kit lot 3232 fluids in use at the site could not be completely ruled out as contributing to the event.Calibrator kit 32 is liquid, ready to use and does not require reconstitution.The calibration fluids are stored refrigerated.The vitros calibrator kit 32 instructions for use states that prior to performing a calibration, the calibrator kit 32 fluids should be handled as follows: 1.Mix the vial thoroughly by gently inverting several times.Do not shake.2.Place fluid in a cup and cover with a pierceable cap.3.Bring the cup to room temperature, 18¿28 °c (64¿82 °f), before analysis (approximately 10 minutes for refrigerated material).It is possible that improper pre-analytical fluid handling contributed to the event however, this cannot be confirmed.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros sodium (na+) results were obtained from a single level of biorad unassayed control lot 92940 using vitros na+ slide lot 4212-1097-5923 on a vitros 5600 integrated system.Biorad lot 92940 level 1 results of 135.7 and 135.5 mmol/l vs.The expected result of 128 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 higher than expected results were obtained from a non-patient quality control sample, however, three unknown samples that may have been patient samples were processed in the timeframe of the event.The customer did not report any 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).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 32
• Common Device Name: IN-VITRO DIGNOSTICS
• 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: 17216858
• Report Number: 0001319808-2023-00013
• Device Sequence Number: 15010698
• Product Code: JIX
• UDI-Device Identifier: 10758750032105
• UDI-Public: 10758750032105
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/27/2023

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: 01/23/2025
• Device Model Number: 6844508
• Device Catalogue Number: 6844508
• Device Lot Number: 3232
• 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: 06/01/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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