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

Model Number	1662659
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a lower than expected sodium result was obtained from a college of american pathologists proficiency sample processed using vitros chemistry products na+ slides lot 4241-1072-7737 on a vitros 5600 integrated system.The assignable cause of the lower than expected vitros na+ result is a suboptimal calibration.The parameters from the calibration used to obtain the lower than expected proficiency sample results were atypical when compared to the database values.Additionally, results from vitros performance verifiers were acceptable using the previous calibration prior to the event but were lower than expected using the suboptimal calibration parameters.Following a recalibration event, quality control results returned to expectations.In addition, the customer reprocessed the proficiency fluids after the recalibration event and the results were acceptable.The cause of the suboptimal calibration is unknown.It is unknown if the customer prepared the calibrators as directed or how the calibrators were handled prior to the calibration event on (b)(6) 2022.Calibrator fluid preparation or handling is a possible contributor of the suboptimal calibration, however it could not be confirmed nor ruled out.Although precision testing was not performed on the vitros 5600 integrated system an instrument related issue is not a likely contributor of the event as historical quality control results were precise.Additionally, results were returned to expectations after a recalibration event without any known troubleshooting actions being performed on the instrument.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros na+ reagent lot 4241-1072-7737.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected sodium (na+) result was obtained from a college of american pathologists (cap) proficiency sample processed using vitros chemistry products na+ slides lot 4241-1072-7737 on a vitros 5600 integrated system.Cap chm-14 result of 144.0 mmol/l vs the expected result of 150.8 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 result was from a proficiency sample.There was no 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).

• 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: 15992000
• Report Number: 0001319808-2022-00600
• Device Sequence Number: 20631551
• Product Code: JIX
• UDI-Device Identifier: 10758750009503
• UDI-Public: 10758750009503
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 12/15/2022

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: 04/17/2024
• Device Model Number: 1662659
• Device Catalogue Number: 1662659
• Device Lot Number: 0262
• 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: 11/17/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2022
• 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