• 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 DIAGNOSTICS

  • 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 DIAGNOSTICS Back to Search Results
Catalog Number 1896836
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that a non-reproducible, higher than expected vitros ck-mb result was obtained from a patient sample when tested using vitros ck-mb reagent pack lot 2890 on a vitros 5600 integrated system. A vitros ck-mb lot 2890 reagent issue cannot be ruled out as a contributor to the event, as there were limited qc results available leading up to the event to verify the performance of the vitros ck-mb lot 2890 reagent. Diagnostic precision testing indicated acceptable performance of the vitros 5600 integrated system following the event, however, as no diagnostic precision testing was performed on the date of the event ((b)(6) 2021), a transient instrument issue cannot be completely ruled out as a contributor to the event. Pre-analytical sample processing could not be ruled out as a contributing factor as it was not possible to determined if the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation. Additionally, the sample viscosity had changed between vitros ck-mb runs. The viscosity value for the first run was 1. 66 (vitros ck-mb result of 26. 84 ng/ml) and the viscosity value for the repeat run was 2. 14 (vitros ck-mb result of 2. 73 ng/ml). Improper pre-analytical sample handling could have contributed to this event. It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed. Heterophilic interference is an unlikely contributor to the event, as further investigational testing using a heterophilic blocking tubes provided concordant results with the expected vitros ck-mb results for the patient. Patient sample mix up is an unlikely contributor to the event, as repeat vitros ck-mb testing immediately after the non-reproducible, higher than expected vitros ck-mb result was metered from the same tray and cup. A definitive assignable cause was not determined. 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 2890. Email address for contact office is (b)(4).
 
Event Description
The investigation determined that a non-reproducible, higher than expected vitros ck-mb result was obtained from a patient sample when tested using vitros ck-mb lot 2890 on a vitros 5600 integrated systems. Vitros ck-mb result of 26. 8 ng/ml versus the expected results of 2. 73 and 3. 23 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 non-reproducible, higher than expected vitros ckmb result was not reported from the laboratory and there was no allegation of 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 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 Key11807897
MDR Text Key265023941
Report Number3007111389-2021-00064
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeIN
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 05/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/10/2021
Device Catalogue Number1896836
Device Lot Number2890
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-