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U.S. Department of Health and Human Services

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

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BIOMERIEUX SA VIDAS BRAHMS PROCALCITONIN 60T VIDAS® BRAHMS PROCALCITONIN 60T Back to Search Results
Catalog Number 30450
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
On (b)(6) 2020 a customer in (b)(6) reported to biomérieux that they observed under-estimated results when using vidas® pct (ref 30450, lot 1008130900, expiry date 06 dec 2021) in a context of external quality control (thermofisher). The customer used two levels; the technical information related to these iqc are reported as follows: - level n1 supplier target: 0. 29 / supplier ranges: 0. 23-0. 365 / customer target: 0. 22 (low) - level n2 supplier target: 2. 40 / supplier ranges: 1. 95-2. 930 / customer target : 2. 73 (acceptable) the results of the last calibration, performed (b)(6) 2020, of vidas pct (lot 1008130900) are reported below: s1 2740/2752 rfv , range: 2034-3632 rfv (acceptable) - s2 523/523 rfv , range: 338-604 rfv (acceptable) - c1 827 rfv 17. 11ng / ml , titer range: 12. 96-20. 24ng / ml (acceptable) - c2 218 rfv 1. 72ng / ml , titer range:1. 34-2. 16ng / ml (low) the customer obtained the following results for the two levels of iqc: for level n1, result at 0. 20; outside supplier ranges (low) - for level n2, results at 1. 94 / 1. 89 / 1. 93; outside supplier ranges (low) the customer performed a new calibration on (b)(6) -2020: s1 2478/2415 rfv , rfv range : 2034-3632 rfv (acceptable) - s2 460/466 rfv , rfv range : 338-604 rfv (acceptable) - c1 758 rfv 17. 53ng / ml , titer range : 12. 96-20. 24ng / ml (acceptable) - c2 201 rfv 1. 79ng / ml, titer range : 1. 34-2. 16ng / ml (acceptable) the customer obtained 0. 24 (acceptable) for level n1 and 2. 17 (acceptable) for level n2 global analysis of the data obtained by the customer was performed by the biomérieux global customer service (gcs) and showed the following results: - for level n1, cumulative mean
=
0. 26 ng/ml range (2sd)
=
0. 19 ¿ 0. 33 ng/ml cv
=
13. 1%. One result was out of range low
=
0. 18 ng/ml. Mobile mean
=
0. 28 ng/ml range (2sd)
=
0. 22 ¿ 0. 33 ng/ml cv
=
9. 6%. Nine results were out of range [manufacturer mean
=
0. 29 ng/ml range
=
0. 23 ¿ 0. 365] - for level n2, : mean
=
2. 463 ng/ml range (2sd)
=
2. 11 ng/ml ¿ 2. 81 ng/ml (cv
=
7. 1%) as there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health. The customer reported that they did not observe this issue with patient samples.
 
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Brand NameVIDAS BRAHMS PROCALCITONIN 60T
Type of DeviceVIDAS® BRAHMS PROCALCITONIN 60T
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 69280
FR 69280
Manufacturer Contact
tenika rhodes
100 rodolphe street
durham, NC 27712
MDR Report Key10623162
MDR Text Key230182192
Report Number8020790-2020-00095
Device Sequence Number1
Product Code PRI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K162827
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 12/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/06/2021
Device Catalogue Number30450
Device Lot Number1008130900
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 Received11/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2020
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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