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 01/12/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros ckmb results were obtained from two different correlation patient samples using vitros ckmb slide lot 4910-0250-9984 on a vitros 5600 integrated system, when compared to results obtained using an alternate vitros ckmb slide lot.Correlation patient sample 2 result of 28 u/l vs.The expected result of 16 u/l correlation patient sample 3 result of 24 u/l vs.The 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 vitros ckmb results were obtained during a patient sample correlation and was not reported from the laboratory.There was no allegation of patient harm as a result of this event.This report is number one of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.(b)(4).

Manufacturer Narrative

The customer reported that higher than expected vitros ckmb results were obtained from two different correlation patient samples using vitros ckmb slide lot 4910-0250-9984 on a vitros 5600 integrated system, when compared to results obtained using an alternate vitros ckmb slide lot.The assignable cause of the event is unknown with the information provided.A vitros ckmb slide lot 4910-0250-9984 performance issue did not likely contribute to the event as historic quality control results were acceptable.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ckmb slide lot 4910-0250-9984.No diagnostic within-run precision testing was performed to assess the performance of the vitros 5600 integrated system, however, since quality control results were acceptable using two different vitros ckmb reagent lots, it is unlikely the vitros 5600 integrated system contributed to the event.The customer provided no information concerning sample processing or handling of the correlation samples.Therefore, pre-analytical sample processing could not be ruled out as a contributing factor, as it was not possible to establish if the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation and cellular debris, due to poor sample preparation, was potentially present in the affected sample, 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: 16397803
• MDR Text Key: 310163016
• Report Number: 0001319809-2023-00002
• 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: 02/17/2023

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: 11/01/2023
• Device Model Number: 8058232
• Device Catalogue Number: 8058232
• Device Lot Number: 4910-0250-9984
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1