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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® BRAHMS PROCALCITONIN 60T - 30450-01

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BIOMERIEUX SA VIDAS® BRAHMS PROCALCITONIN 60T - 30450-01 Back to Search Results
Model Number 30450-01
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to the manufacturer.
 
Event Description
A customer in the united states notified biomérieux of obtaining a bad correlation result between two lots of vidas® brahms procalcitonin 60t (ref. 30450-01 lots, 1007419860 and 1007448940). The customer stated that they obtained discrepant results while performing a ¿crossover¿ test between the current lot (1007419860) and the new lot (1007448940) of vidas ® brahms procalcitonin. The results were as follows: sample 1 lot 1007419860: pct result
=
69 ng/ml; sample 1 lot 1007448940: pct result
=
48 ng/ml; sample 2 lot 1007419860: pct result
=
0. 46 ng/ml; sample 2 lot 1007448940: pct result
=
0. 34 ng/ml; sample 3 lot 1007419860: pct result
=
0. 13 ng/ml; sample 3 lot 1007448940: pct result
=
0. 09 ng/ml. Per the ranges listed in the vidas® brahms procalcitonin 60t ifu the interpretation of sample 1 changed from ¿> 0. 50 ng/ml suggestive of presence of bacterial infection. Antibiotic therapy strongly recommended¿ to ¿ results between 0,26-0,50 ng/ml bacterial infection is possible. Antibiotic therapy recommended. ¿ there is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.
 
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Brand NameVIDAS® BRAHMS PROCALCITONIN 60T - 30450-01
Type of DeviceVIDAS® BRAHMS PROCALCITONIN 60T - 30450-01
Manufacturer (Section D)
BIOMERIEUX SA
chemin de l orme
marcy l etoile, rhone 69280
FR 69280
Manufacturer (Section G)
BIOMERIEUX SA
chemin de l orme
marcy l etoile, rhone 69280
FR 69280
Manufacturer Contact
jennifer armstrong
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key9505764
MDR Text Key219779416
Report Number8020790-2019-00074
Device Sequence Number1
Product Code PRI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162827
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 03/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/16/2020
Device Model Number30450-01
Device Catalogue Number30450-01
Device Lot Number1007448940
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 Received02/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2019
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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