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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® BRAHAMS PROCALCITONIN VIDAS® BRAHAMS PCT

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BIOMERIEUX SA VIDAS® BRAHAMS PROCALCITONIN VIDAS® BRAHAMS PCT Back to Search Results
Catalog Number 30450-01
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A customer in the united states reported that they obtained a false low result for their cap survey sample, using the vidas® brahams procalcitonin (pct) assay, lot 1006974220. The customer stated the qc was within range using kit controls. S1 rfv was 2077 (range 1748 - 3122; mean 2435); s2 rfv 424 (range 292 - 521; mean 406. 5); c1 18. 10 ng/ml (range 12. 95 - 20. 23ng/ml); c2 1. 86 ng/ml (range 1. 33 - 2. 15 ng/ml); qc result of 5. 64 ng/ml ( expected value range was 6. 21 - 8. 56 ng/ml). According to the cap survey report: pct-01 : customer s result 5. 64 ng/ml peer group mean
=
7. 386 ng/ml range [6. 21-8. 56]
=
> out of range too low; pct-02 : customer s result < 0. 05 ng/ml not evaluated; pct-03 : customer s result 1. 96 ng/ml peer group mean
=
2. 240 ng/ml range [1. 86-2. 67]. A biomérieux internal investigation will be initiated.
 
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Brand NameVIDAS® BRAHAMS PROCALCITONIN
Type of DeviceVIDAS® BRAHAMS PCT
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
3145068201
MDR Report Key8669246
MDR Text Key213479409
Report Number8020790-2019-00031
Device Sequence Number1
Product Code PRI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071146
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/27/2019
Device Catalogue Number30450-01
Device Lot Number1006974220
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 Received08/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/05/2018
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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