MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number 1896836

Device Problem Low Test Results (2458)

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

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined lower than expected ckmb results were obtained when a non-vitros (mas) qc fluid was tested using vitros ckmb lot 2980 and vitros ckmb lot 3050 on a vitros 5600 integrated system.The lower than expected vitros ckmb results that met potential health and safety criteria were obtained over the timeframe of (b)(6) 2021 through to (b)(6) 2021.A definitive assignable cause was not determined.Lower than expected ckmb results were obtained on two different lots of vitros ckmb reagents (lot 2980 and lot 3050), therefore, issues with the two lots of vitros ckmb reagent packs is an unlikely contributor to the event.However, unacceptable within laboratory precision was observed with vitros ckmb results from mas qc fluid testing over the course of the investigation, therefore a vitros ckmb lot 2980 or lot 3050 reagent issue cannot be completely ruled out as a contributor to the event.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ck-mb reagent lot 2980 and lot 3050.No information was provided in relation to the handling and storage of the mas l1 qc fluid.It is possible the customer was not preparing the mas qc fluids according to protocol or using the mas qc fluids past their stability, owing to the poor precision and lower than expected results observed from vitros ckmb testing, however this could not be confirmed.Diagnostic precision testing indicated acceptable performance of the vitros 5600 integrated system on (b)(6) 2021.However, an instrument issue cannot be ruled out as a contributor to the lower than expected vitros ckmb results on (b)(6) 2021, (b)(6) 2021 as no diagnostic precision testing was conducted on the instrument to verify its performance around these times.Additionally, an instrument issue is a potential cause of the event, as issues with results from other vitros microwell assays were observed when different qc fluids were tested on the instrument.On (b)(6) 2021, an ortho field engineer (fe) visited the customer site following issues with multiple vitros microwell reagent assay results from different qc fluids.The fe replaced the sr tips and probes.All metering assemblies were inspected and cleaned.The microwell incubator and luminometer were also cleaned.The ortho fe also performed an incubator reference system (irs) calibration after luminometer performance tests following service actions.Vitros ckmb results from mas qc fluid testing following ortho fe actions demonstrated acceptable accuracy and also indicated the within laboratory precision had improved.(b)(4).

Event Description

The investigation determined lower than expected ckmb results were obtained when a non-vitros (mas) qc fluid was tested using vitros ckmb lot 2980 and vitros ckmb lot 3050 on a vitros 5600 integrated system.Mas cardioimmune xl qc fluids, lot cxl21121a (level ) results of 3.073, 2.971, 2.458, 2.402, 1.861, 1.818, 3.014, 2.952 and 2.999 ng/ml versus the mas (b)(6) 2021 peer mean result of 4.10 ng/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected vitros ckmb results were obtained when the customer was processing a non-patient fluid.There was no reported issues with patient sample results.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number one of five mdr¿s for this event.Five 3500a forms are being submitted for this event as five devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 12933509
• MDR Text Key: 285825533
• Report Number: 3007111389-2021-00173
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2022
• Device Catalogue Number: 1896836
• Device Lot Number: 2980
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1