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U.S. Department of Health and Human Services

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

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ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK IN-VITRO DIAGNOSTICS Back to Search Results
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).
 
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Brand NameVITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
Type of DeviceIN-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 Key12933509
MDR Text Key285825533
Report Number3007111389-2021-00173
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 12/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/21/2022
Device Catalogue Number1896836
Device Lot Number2980
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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