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

Catalog Number	1882208
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
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 lactate (lac) results were obtained when processing non-vitros biorad quality control fluids and vitros performance verifiers.Biorad multiqual controls, lot 56743, vitros lac results of 7.52 and 7.58 mmol/l versus the baseline mean of 5.39 mmol/l vitros performance verifier 2, lot u1398 vitros lac results of 5.12 and 5.16 mmol/l versus the midpoint of the range of means 3.71 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 vitros lac results were obtained when processing quality control fluids.No allegation of patient harm has been made as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation concludes that higher than expected vitros lactate (lac) results were obtained when processing non-vitros biorad quality control fluids and vitros performance verifiers.The cause of the higher than expected vitros lac result is a suboptimal calibration caused by an error in reconstituting vitros calibrator kit 1 fluids.The customer was using a 10 ml pipette filling to the 3 ml line instead of a fixed volume 3ml pipette.Acceptable vitros lac results were obtained after calibrating with a new set of calibrators reconstituted using a fixed volume pipette.

• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 19187882
• Report Number: 1319808-2024-00014
• Device Sequence Number: 17966626
• Product Code: JIX
• UDI-Device Identifier: 10758750000166
• UDI-Public: 10758750000166
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/25/2024

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: 10/30/2025
• Device Catalogue Number: 1882208
• Device Lot Number: 0183
• 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: 03/29/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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