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

Model Number 8058232

Device Problem High Test Results (2457)

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

Event Date 02/03/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros ckmb result was obtained from a patient sample processed during a reagent lot to lot correlation test using vitros chemistry products ckmb slides lot: 4912-0253-3587 on a vitros 5600 integrated system.Patient 2 sample vitros ckmb result of 28 u/l vs an expected result of 16 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 higher than expected patient sample result was obtained during correlation testing and no results were reported from the laboratory.Ortho has not been made aware of any 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 601026.

Manufacturer Narrative

The investigation has determined that a higher than expected vitros ckmb result was obtained from a patient sample processed during a reagent lot to lot correlation test using vitros chemistry products ckmb slides lot: 4912-0253-3587 on a vitros 5600 integrated system.Based on the limited information provided, a definitive assignable cause of the event was unable to be determined.As no quality control results were provided, a vitros ckmb lot: 4912-0253-3587 performance issue cannot be ruled out as a contributor of the event.However, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ckmb lot: 4912-0253-3587.As precision testing was not performed on the vitros 5600 integrated system, an instrument related issue cannot be completely ruled out as a contributor of the event.However, there was no indication that the vitros 5600 system malfunctioned.Additionally, pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not following the sample collection device manufacturer¿s recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.

• 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: 16494766
• MDR Text Key: 310899220
• Report Number: 0001319809-2023-00017
• Device Sequence Number: 1
• Product Code: JHS
• UDI-Device Identifier: 10758750004294
• UDI-Public: 10758750004294
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/06/2023

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: 03/01/2024
• Device Model Number: 8058232
• Device Catalogue Number: 8058232
• Device Lot Number: 4912-0253-3587
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1