MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2; IN-VITRO DIAGNOSTICS

Model Number	1662659
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros potassium (k+) results were obtained from a single level of non-vitros biorad multiqual unassayed control, lot 56700 tested on a vitros xt7600 integrated system.Biorad level 1 results of 4.38 and 4.31 mmol/l, vs.The expected result of 2.60 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 customer stated that patient sample results were affected by the event however, no examples of higher than expected vitros k+ patient sample results were provided by the customer.In addition, the customer stated that no higher than expected vitros results were reported outside the laboratory.There was no reported 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 600594.
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros potassium (k+) results were obtained from a single level of non-vitros biorad multiqual unassayed control, lot 56700 tested on a vitros xt7600 integrated system.The assignable cause of the event is a suboptimal calibration.The calibration responses and parameters obtained from the affected calibration appeared atypical to expected responses and parameters.The cause of the suboptimal calibration could not be determined.Acceptable vitros k+ performance was obtained after retesting the same lot of biorad controls after recalibrating the affected vitros k+ slide lot (lot 4102-1091-5006).A vitros k+ slide lot 4102-1091-5006 performance issue did not likely contribute to the event as acceptable performance was obtained after calibrating vitros k+ slide lot 4102-1091-5006 with the same lot of calibrators.A vitros xt7600 integrated system performance issue was not a likely contributor to the event as acceptable vitros k+ performance was obtained on the same vitros xt7600 integrated system after calibrating vitros k+ slide lot 4102-1091-5006 with the same lot of calibrators, without performing any additional actions to optimize the instrument performance.

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
• 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: 16253894
• Report Number: 0001319808-2023-00003
• Device Sequence Number: 17480539
• Product Code: JIX
• UDI-Device Identifier: 10758750009503
• UDI-Public: 10758750009503
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 01/26/2023

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: 10/10/2024
• Device Model Number: 1662659
• Device Catalogue Number: 1662659
• Device Lot Number: 0272
• 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: 01/01/2023
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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