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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CK-MB SLIDES IN-VITRO DIAGNOSTICS

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ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CK-MB SLIDES IN-VITRO DIAGNOSTICS Back to Search Results
Catalog Number 8001133
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation has determined that lower than expected vitros ck-mb results were obtained from vitros isoenzyme performance verifiers and lower than expected vitros bu results were obtained from vitros performance verifiers processed using vitros chemistry products ck-mb slides and vitros chemistry products bubc slides on a vitros 250 chemistry system. Based on the limited information provided, the assignable cause of the lower than expected vitros ck-mb and vitros bu quality control results is improper protocol related to the preparation of the vitros calibrators and vitros control fluids. After an operator prepared vitros calibrators and vitros control fluids and processed them on the vitros 250 system, qc results were lower than expected for vitros ck-mb and vitros bu. An alternate operator then prepared fresh vials of vitros calibrators and vitros control fluids and processed them on the vitros 250 system. Qc results for both vitros ck-mb and vitros bu returned to expectations. No historical qc results were provided; however, a reagent issue is not likely a contributor of the event as expected qc results were obtained after fresh vials of vitros calibrators and vitros control fluids were prepared and processed by an alternate operator. Although precision testing was not performed on the vitros 250 chemistry system an instrument related issue is not a likely contributor of the event as qc results returned to within expectations after recalibration events without any known troubleshooting actions being performed on the instrument. Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ck-mb lot 4903-0239-4310 or vitros bubc lot 0246-0428-5626. Email address for contact office above is: (b)(6).
 
Event Description
The investigation has determined that lower than expected vitros ck-mb results were obtained from vitros isoenzyme performance verifiers and lower than expected vitros bubc results were obtained from vitros performance verifiers processed using vitros chemistry products ck-mb slides and vitros chemistry products bubc slides on a vitros 250 chemistry system. The magnitude of bias of the vitros ck-mb and vitros bu results meets potential health and safety criteria and the results are reportable. Vitros ipv i lot h8087 vitros ck-mb results of 0. 7 and 0. 7 u/l vs an expected result of 19 u/l vitros pv ii lot l7425 vitros bu result of 0. 07 mg/dl vs an expected result of 8. 85 mg/dl. 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 results were obtained from quality control fluids and no results were reported from the laboratory. No patient sample results were affected. Ortho has not been made aware of any 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. This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).
 
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Brand NameVITROS CHEMISTRY PRODUCTS CK-MB SLIDES
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 Key11898016
MDR Text Key266942079
Report Number1319809-2021-00094
Device Sequence Number1
Product Code JHS
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 05/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2022
Device Catalogue Number8001133
Device Lot Number4903-0239-4310
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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