• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ORTHO CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK IN-VITRO DIAGNOSTIC Back to Search Results
Catalog Number 1896836
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation confirmed that higher than expected ckmb results were obtained from a patient sample processed using vitros ckmb reagent lot 2960 on a vitros 5600 integrated system. The assignable cause of the event was not determined. The patient has breast cancer was receiving chemotherapy. It is possible that the higher than expected vitros ckmb results are due to an unknown sample related issue that only impacts the vitros assay and not the beckman assay. However, no additional investigation was performed to confirm or rule out a sample related issue. The ckmb quality control results were reviewed and some of the results around the time of the event were unacceptable. In addition, there was no documentation to confirm pre-analytical qc fluid handling and storage. No definitive conclusion can be made regarding the qc performance in combination with vitros ckmb lot 2960 and a vitros ckmb reagent issue could not be ruled out as a potential contributing factor to the event. There was no evidence of an instrument malfunction. However, diagnostic precision testing was not conducted on the instrument around the time of the event. Therefore, an instrument issue cannot be ruled out as a contributor to the event. The sample was a serum sample spun for 5 minutes at an rcf 2860. The tube manufacturer was not provided and therefore it is unknown if the sample was processed in accordance with the sample collection device manufacturer's recommendations. Therefore, a pre-analytical sample handling cannot be ruled out as a potential contributing factor to the event. A complaint review found no additional complaints for qc high or precision issues using this ckmb lot. In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with this vitros ckmb lot 2960. A definitive assignable cause for the event could not be determined. Email address for contact office in is (b)(4).
 
Event Description
A customer observed higher than expected ckmb results from a patient sample processed using vitros ckmb reagent lot 2960 on a vitros 5600 integrated system. Vitros ckmb results of > 20 and >20 ng/ml versus the expected results of 0. 8, 0. 6 ng/ml (beckman). Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The higher than expected ckmb results were not reported from the laboratory and there was no allegation of actual patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint number (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
Type of DeviceIN-VITRO DIAGNOSTIC
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 Key11664511
MDR Text Key265020269
Report Number3007111389-2021-00047
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeCH
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 04/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/26/2021
Device Catalogue Number1896836
Device Lot Number2960
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-