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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® CK MB

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BIOMERIEUX SA VIDAS® CK MB Back to Search Results
Catalog Number 30421
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in (b)(6) reported a falsely elevated result for an external quality control (eqa) sample in association with the vidas® ck mb assay (lot: 1006158480). The customer reported that for cycle 8, sample 1 the result was too high. The customer stated that eqa was performed once per month and the assay was repeated with similar results. There was no patient involvement as the event pertained to a quality control sample. The customer stated other testing was then performed on different analyzers at different labs. The biomérieux local application specialist requested samples from two different labs to cross check but high results were obtained. A biomérieux internal investigation will be initiated.
 
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Brand NameVIDAS® CK MB
Type of DeviceVIDAS® CK MB
Manufacturer (Section D)
BIOMERIEUX SA
chemin de l orme
marcy l etoile, rhone 69280,
FR
Manufacturer (Section G)
BIOMERIEUX SA
chemin de l orme
marcy l etoile, rhone 69280,
FR
Manufacturer Contact
debra broyles
595 anglum road
hazelwood, MO 63042
MDR Report Key8286105
MDR Text Key136858753
Report Number8020790-2019-00007
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeSF
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 03/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/11/2018
Device Catalogue Number30421
Device Lot Number1006158480
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 Received02/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2017
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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