MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CKMB SLIDES; IN-VITRO DIAGNOSTICS

Model Number 8001133

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros ckmb results were obtained from a riqas external quality control fluid and from a vitros isoenzyme performance verifier (pv) fluid when running vitros ckmb lot 4903-0248-4599 on a vitros 5600 integrated system.Vitros ckmb riqas cycle 44 sample 1 result of 10.0 u/l versus the expected result of 19.098 u/l vitros isoenzyme pvi lot m8776 results of 12.82 and 8.40 u/l versus the expected result of 20.5 u/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 made no indication that patient results from the time frame of the event were in question and there was no allegation of patient harm as a result of this event.Ortho has not been made aware of any allegation of harm as a result of this event.This report is number one of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 601910.

Manufacturer Narrative

The investigation determined that lower than expected vitros ckmb results were obtained from a riqas external quality control fluid and from a vitros isoenzyme performance verifier (pv) fluid when running vitros ckmb lot 4903-0248-4599 on a vitros 5600 integrated system.The assignable cause of the event cannot be determined with the information provided.Historical vitros ckmb lot 4903-0248-4599 results indicated that this reagent lot was not performing as expected with regards to precision at higher concentrations, therefore a reagent issue cannot be fully ruled out as a contributor to the event.The customers current in use reagent lot is performing as expected.Additionally, a diagnostic vitros ckmb precision test that was run recently using the customers new in-use lot of vitros ckmb and a new lot of vitros pvi fluid was within ortho acceptable guidelines.However, since no diagnostic precision testing was performed within the timeframe of the events using the reagent lot or pv fluid lot in question, issues with instrument, reagent, or pv fluid lot performance cannot be completely ruled out as contributing to the event.Continual tracking and trending does not indicate a systemic issue with vitros ckmb lot 4903-0248-4599.It is unknown if there was an issue with the qc fluid and the proficiency fluid in use at the time of the events contributed to the lower than expected results.The customer was not following correct fluid handling protocol and was using expired pv fluids at the time that the incident was reported, however the two phs results obtained using the pv fluids were obtained prior to the fluid expiration.The handling of the qc fluid sample was not provided.

• Brand Name: VITROS CHEMISTRY PRODUCTS CKMB SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16952053
• MDR Text Key: 315468948
• Report Number: 0001319809-2023-00040
• Device Sequence Number: 1
• Product Code: JHS
• UDI-Device Identifier: 10758750004201
• UDI-Public: 10758750004201
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: 8001133
• Device Catalogue Number: 8001133
• Device Lot Number: 4903-0248-4599
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1