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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 False Positive Result (1227)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/23/2018
Event Type  malfunction  
Event Description
A customer in (b)(6) reported to biomérieux falsely elevated results when testing with vidas® ck mb (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 in this event was diagnosed with nste-acs one year ago. The patient has had multiple samples tested with results as follows: on (b)(6) 2017: 27. 41 ng/ml (24. 75 ng/ml repeated on vidas), on (b)(6) 2017: >300 ng/ml (>300 ng/ml repeated on vidas). Ckmb mass retested on roche cobas®: 0. 95ng/ml (0-6. 22 ng/ml ). On (b)(6) 2017: 53. 42 ng/ml (53. 93 ng/ml repeated on vidas). Ckmb mass retested on cobas: 0. 78 ng/ml (0-6. 22 ng/ml ). On (b)(6) 2018: 11. 09 ng/ml. On (b)(6) 2018: 86. 66 ng/ml. On (b)(6) 2018: 67. 79 ng/ml. Ckmb mass retested on cobas: 0. 80 ng/ml (0-6. 22 ng/ml). The physicians determined that the negative ck-mb results were more consistent with the clinical symptoms of the patient. The patient is reported as doing well and that these elevated ck-mb results had no influence on the treatment of the patient. The customer reported that patient results were not affected, both lab results were reported to the physician, no patient was harmed or treated incorrectly, and the delay in reporting results was one half to one day due to retesting the samples. An internal biomérieux investigation will be initiated.
 
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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
saint louis, MO 63042
MDR Report Key7720889
MDR Text Key115367045
Report Number3002769706-2018-00117
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeCH
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 09/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number30421
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 Received08/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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