NUCLISENS? EASYMAG? DISPOSABLE 280135

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-01-27 for NUCLISENS? EASYMAG? DISPOSABLE 280135 manufactured by Biom?rieux Sa.

Event Text Entries

[66004416] A customer from the (b)(6) contacted biom? Rieux to report intermittent lls errors in association with the nuclisens? Easymag? Disposable vessels used on two of their easymag? Systems. The customer changed to a different lot and the issue was resolved. The customer was able to recover elutes from samples tested. All elutes could be used apart from the last run, which failed all samples. The customer reported results were delayed with no impact to patient care. The test reports and disposables were requested from the customer. A biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


[71106564] An internal biom? Rieux investigation was performed. During the investigation, the issue was reproduced with samples but with a lower frequency. The analysis of data provided by customers showed that these errors were randomly distributed within the run sequences and the sample positions. Investigation with the disposable supplier revealed no issue in raw materials use. The issue involves risk of delayed results for the patients, but not false results. As mentioned in the easymag user manual, the use of an internal control is recommended in order to detect potential nucleic acid extraction issue. All errors that occur during the runs can be found in the results report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3002769706-2017-00010
MDR Report Key6282723
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-01-27
Date of Report2017-03-10
Date Mfgr Received2017-02-15
Date Added to Maude2017-01-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactELLEN WELTMER
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityST. LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147317301
Manufacturer G1BIOM
Manufacturer Street5, RUE DES BERGES
Manufacturer CityGRENOBLE CEDEX 01, FR 38024
Manufacturer CountryFR
Manufacturer Postal Code38024
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNUCLISENS? EASYMAG? DISPOSABLE
Generic NameNUCLISENS? EASYMAG? DISPOSABLE
Product CodeJJH
Date Received2017-01-27
Catalog Number280135
Lot NumberZ107NB
Device Expiration Date2017-11-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBIOM?RIEUX SA
Manufacturer Address5, RUE DES BERGES GRENOBLE CEDEX 01, FR 38024 FR 38024


Patients

Patient NumberTreatmentOutcomeDate
10 2017-01-27

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