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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® GDH

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BIOMERIEUX SA VIDAS® GDH Back to Search Results
Catalog Number 30125
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in (b)(6) notified biomérieux of a false positive result associated with vidas® gdh (reference (b)(4)).The customer reported while performing a correlation study between two (2) vidas®3 analyzers for vidas® gdh the discrepancy was observed.The results were as follows: sample 1: stool volume was not doubled; the liquid stool sample had clear separation and perfect supernatant.1st test on vidas® (b)(4) was obtained positive at 0.15.2nd test on vidas® (b)(4) was obtained negative at 0.00.Sample 2: doubled stool volume and volume of r1.1st test on vidas® 3 (b)(4) was obtained negative at 0.00.2nd test on vidas® 3 (b)(4) was obtained negative at 0.05.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.
 
Manufacturer Narrative
A customer in france had notified biomérieux of a false positive result associated with vidas® gdh (reference 30125).An internal biomérieux investigation was performed.Batch record review: there is no capa nor non-conformity recorded on vidas gdh 1006161620/190127-0 linked to the customer's issue.The analysis of the batch history records of vidas gdh 1006161620/190127-0 showed no anomaly during the manufacturing and control processes.Study of internal samples control charts: analysis was made on four (4) internal samples with different concentrations and on seven (7) batches including the batch mentioned by the customer.Vidas gdh batch 1006161620/190127-0 is in the trend analysis compared to the other batches.Testing by biomérieux: four (4) internal samples were tested (two stools to prepare gdh002 & gdh005 and two supernatants ready to use gdh027 & gdh031) and calibration on two (2) vidas 3 instruments.(b)(4).All of the results were within their specification and the same between the two (2) instruments.The vidas gdh 1006161620/190127-0 is within the expected performance.The customer's issue was not reproduced.Conclusion: according to the data mentioned above, vidas gdh, batch 1006161620/190127-0, performed as expected.
 
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Brand Name
VIDAS® GDH
Type of Device
VIDAS® GDH
Manufacturer (Section D)
BIOMERIEUX SA
376, chemin de l'orme
marcy l'etoile, 69280
FR  69280
MDR Report Key7544663
MDR Text Key109772016
Report Number3002769706-2018-00070
Device Sequence Number1
Product Code MCB
Combination Product (y/n)N
PMA/PMN Number
K132010
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 07/11/2018
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 Date01/27/2019
Device Catalogue Number30125
Device Lot Number1006161620
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/01/2018
Initial Date FDA Received05/25/2018
Supplement Dates Manufacturer Received06/12/2018
Supplement Dates FDA Received07/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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