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

Catalog Number 8058232

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros ck-mb results were obtained from multiple patient samples when run on a vitros 5600 integrated system.The results were considered lower compared to results obtained from the same samples tested using a non-vitros analyzer.The investigation was unable to determine the assignable cause of the event.The ortho technical solution center (tsc) was unable to obtain any other assay results or any specific clinical information regarding the patients.However, the customer reported the vitros ckmb results do not match the patient diagnosis.The tsc was unable to obtain any details regarding the pre-analytical sample collection, handling and storage of the samples used in the comparison and therefore, pre-analytical sample handling cannot be ruled out as a potential contributing factor.A review of quality control results for the month of february 2019 concluded that the performance of the vitros performance verifiers was acceptable; however, the quality control fluids were only processed 5-6 times the entire month of february.There are not enough qc data points processed in february 2019 to truly access the overall performance of the assay and therefore a ckmb lot 4940-0221-7109 issue cannot be ruled out as a contributing factor to this event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with this lot of vitros ckmb slides.The tsc requested the customer process within run precision testing to confirm performance of the reagent and the analyzer.The precision testing has not been completed at this time and an instrument issue cannot be ruled out as a contributor to this event.

Event Description

A customer obtained lower than expected vitros ck-mb results from multiple patient samples run on a vitros 5600 integrated system.The results were considered lower compared to results obtained from the same samples tested using a non-vitros analyzer.Sample 2 vitros = 5 u/l versus abbott architect 54 u/l.Sample 4 vitros = <3 u/l versus abbott architect 38 u/l.Sample 5 vitros = <3 u/l versus abbott architect 44 u/l.Sample 6 vitros = <3 u/l versus abbott architect 79 u/l.Sample 7 vitros = <3 u/l versus abbott architect 29 u/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected vitros ck-mb results were not reported from the laboratory.There was not allegation of actual patient harm as a result of this event.This report is number two of five mdr¿s for this event.Five 3500a forms are being submitted for this event as a total of five devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CKMB SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 8470435
• MDR Text Key: 143988972
• Report Number: 1319809-2019-00018
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Reporter Country Code: BK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/01/2019
• Device Catalogue Number: 8058232
• Device Lot Number: 4940-0221-7109
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1