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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 False Negative Result (1225)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Note: reference 30450 is not registered in the united states.The u.S.Similar device is product reference 30450-01.A customer from (b)(6) notified biomérieux of obtaining 2 falsely under estimated procalcitonin results in association with the vidas® brahms procalcitonin 60t tests (ref.30450, lot 1008130900) when testing 2 separate samples.The customer obtained the following results: test 1: sample (b)(6): value < 0.05 ng/ml.Sample (b)(6): value < 0.05 ng/ml.Test 2: sample (b)(6): value = 52.46 ng/ml.Sample (b)(6): value = 2.25 ng/ml.The customer confirmed the minividas® instrument used to test the sample passed weekly qcv testing.The initial results of < 0.05 ng/ml indicated the sample cones may have been missing from both initial tests.Local customer service required the customer to count the sample cones; however, this information has not been provided.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.Biomerieux will initiate an internal investigation.
 
Manufacturer Narrative
This report was initially submitted following notification from a customer in brazil regarding two (2) falsely under-estimated procalcitonin (pct) results in association with the vidas® brahms procalcitonin 60t tests (ref.(b)(4) , lot 1008130900) when testing two (2) separate samples.The customer¿s samples were not available to be submitted for the investigation.According to the analysis of the quality data, no anomalies were identified during the manufacturing, control and packaging processes for vidas® brahms pct ref (b)(4) batch 1008130900/ 211206-0.The investigation unit laboratory tested six (6) internal samples on the retain kit of vidas® brahms procalcitonin ref (b)(4) lot 1008130900 / 211206-0.The results of the samples complied with the standards, and were close to the results obtained during the release of the lot.There was no drift of the lot identified.The customer¿s initial results of <0.05 ng/ml indicated the sample cones (spr - solid phase receptacle) may have been missing from both initial tests.Local customer service required the customer to count the sample cones; however, this information has not been provided.The root cause of the complaint could not be determined.Based on internal data and information provided by the customer, a potential root cause of the complaint is operator error linked to the absence of the spr.There is no reconsideration of the performance of product vidas® brahms pct ref (b)(4) batch 1008130900/211206 to its expectations.
 
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Brand Name
VIDAS BRAHMS PROCALCITONIN 60T
Type of Device
VIDAS® BRAHMS PROCALCITONIN 60T
Manufacturer (Section D)
BIOMERIEUX SA
chemin de l orme
marcy l etoile, rhone 69280
FR  69280
MDR Report Key11374776
MDR Text Key269877678
Report Number8020790-2021-00015
Device Sequence Number1
Product Code PRI
Combination Product (y/n)N
PMA/PMN Number
K162827
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/06/2021
Device Catalogue Number30450
Device Lot Number1008130900
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/27/2021
Initial Date FDA Received02/24/2021
Supplement Dates Manufacturer Received03/25/2021
Supplement Dates FDA Received04/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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