NUCLISENS? MAGNETIC SILICA 280133

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-15 for NUCLISENS? MAGNETIC SILICA 280133 manufactured by Biomerieux, Sa.

Event Text Entries

[134883052] A customer in the united states reported a performance problem with nuclisens? Magnetic silica when extracting urine samples on the easymag? Instrument for two patients (a & b). The customer stated that results for the same patient when tested at different volumes, gave really different results downstream. The downstream application was run as a quantitative assay for bk virus. The customer ran the test on patient a in duplicate. The extraction was performed two different ways, they first ran the urine in duplicate for a volume of 500? L with an eluate of 60? L and the second was 200? L with an eluate of 50? L. Downstream for bk virus they recovered a result of 4. 3 million for the sample that had 500? L volume and they obtained 26000 for the 200? L volume sample. For patient b the customer also ran this in duplicate and they reported that they first ran the urine in duplicate for a volume of 500? L with an eluate of 60? L and the second was 200? L with an eluate of 50? L. Downstream for bk virus they recovered a result of 8,000 for the sample that had 500? L volume and they obtained 763,000 for the 200? L volume sample. The customer reported that samples for patient a and b were sent to a reference lab at 3-4 days for results to be reported out. There was no wrong result reported to a physician, and the patient treatment was not impacted. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008249922-2019-00001
MDR Report Key8248573
Date Received2019-01-15
Date of Report2019-03-19
Date Mfgr Received2019-02-20
Date Added to Maude2019-01-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. DEBRA BROYLES
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1BIOMERIEUX, SA
Manufacturer Street5 RUE DES BERGES
Manufacturer City38024 GRENOBLE, CEDEX 01
Manufacturer CountryFR
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameNUCLISENS? MAGNETIC SILICA
Generic NameNUCLISENS? MAGNETIC SILICA
Product CodePPM
Date Received2019-01-15
Catalog Number280133
Lot NumberZ019FE1MS
Device Expiration Date2019-06-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerBIOMERIEUX, SA
Manufacturer Address5 RUE DES BERGES 38024 GRENOBLE, CEDEX 01 FR

Device Sequence Number: 1

Brand NameNUCLISENS? MAGNETIC SILICA
Generic NameNUCLISENS? MAGNETIC SILICA
Product CodeLTD
Date Received2019-01-15
Catalog Number280133
Lot NumberZ019FE1MS
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, SA
Manufacturer Address5 RUE DES BERGES 38024 GRENOBLE, CEDEX 01 FR


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-15

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