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

MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® CK MB

  • 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
 

BIOMERIEUX SA VIDAS® CK MB Back to Search Results
Catalog Number 30421
Device Problem False Positive Result (1227)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2018
Event Type  malfunction  
Event Description
A customer from (b)(6) notified biomérieux of obtaining elevated ck-mb results for a (b)(6) boy in association with the vidas® ck mb assay (ref (b)(4)). Although product reference (b)(4) is not sold/ distributed in the united states, a similar product is (reference (b)(4)). The patient had complained of a stabbing pain his chest after exercise. He had moved benches at school and played football. He was admitted to the children's ward for observation, and labs were drawn showing the following results: (b)(6) 2018: troponin - 10. 1 ng / ml, ck-mb - 116. 15 ng / ml, ecg - normal. (b)(6) 2018: troponin - 3. 6 ng / ml, ck-mb - 133. 97 ng / ml. (b)(6) 2018: ck-mb - 202. 99 ng / ml, repeated in serum diluted 11 times
=
17. 1 ng / ml x 11
=
188. 1 ng / ml. The chest pain was transient, and the patient was reported by the customer as feeling well. As the vidas ck-mb test was performed after a sport exercise at school, the elevation of ck-mb could have been due to muscular hyperactivity. However, the result continued to increase. The customer reported testing one of the patient samples with the vidas ckmb assay and obtaining a > 300 result. This same sample was testing with cobas® (roche diagnostics), and it returned a ck-mb result in the normal range. The customer reported that the patient was discharged home without treatment. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. Note: the two techniques, vidas and cobas, use different technologies and different antibodies for the detection of ck-mb. An internal biomérieux investigation will be initiated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVIDAS® CK MB
Type of DeviceVIDAS® CK MB
Manufacturer (Section D)
BIOMERIEUX SA
376 chemin de l orme
marcy l etoile, rhone 69280
FR 69280
Manufacturer (Section G)
BIOMERIEUX SA
376 chemin de l orme
marcy l etoile, rhone 69280
FR 69280
Manufacturer Contact
candace martin
595 anglum road
hazelwood, MO 63042
MDR Report Key8056317
MDR Text Key129157436
Report Number3002769706-2018-00235
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K962549
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/17/2019
Device Catalogue Number30421
Device Lot Number1006271330
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-