EASYMAG? INSTRUMENT 200111

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 2018-07-26 for EASYMAG? INSTRUMENT 200111 manufactured by Biomerieux Sa.

Event Text Entries

[115685088] A customer in france notified biom? Rieux of potential contamination associated with easymag? Instrument (reference (b)(4)). The customer reported that the laboratory suspects contamination with vzc (altona pcr) since (b)(6) 2018. The first two samples have a high signal of positivity with vzv. Six (6) samples were positive with vzv with a value greater than 31. The laboratory decided to retest these samples the next day. Four (4) of the samples tested positive. Results were reported as follows: results : swt1 = negative hsv and vzv; swt2 = ct value = 29. 9 for hsv1 and 42 for vzv; swt3 = negative hsv and vzv; swt4 = negative hsv and vzv contamination. Patients samples: (b)(6) positive with ct = 29 for hsv1. Id 2706619 positive with ct = 38 vzv. However, the negative control tests (pbs and w0) were negative. 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 biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002769706-2018-00114
MDR Report Key7723642
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-07-26
Date of Report2018-12-04
Date Mfgr Received2018-11-08
Date Added to Maude2018-07-26
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. TIFFANY HALL
Manufacturer Street100 RODOLPHE STREET
Manufacturer CityDURHAM NC 27712
Manufacturer CountryUS
Manufacturer Postal27712
Manufacturer G1BIOMERIEUX SA
Manufacturer StreetVIA DI CAMPIGLIANO 58 - LOC. PONTE A EMA
Manufacturer City50012 BAGNO A RIPOLI,
Manufacturer CountryIT
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameEASYMAG? INSTRUMENT
Generic NameEASYMAG? INSTRUMENT
Product CodeJQW
Date Received2018-07-26
Model Number200111
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerBIOMERIEUX SA
Manufacturer AddressVIA DI CAMPIGLIANO 58 - LOC. PONTE A EMA 50012 BAGNO A RIPOLI, IT

Device Sequence Number: 1

Brand NameEASYMAG? INSTRUMENT
Generic NameEASYMAG? INSTRUMENT
Product CodeJJH
Date Received2018-07-26
Model Number200111
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX SA
Manufacturer AddressVIA DI CAMPIGLIANO 58 - LOC. PONTE A EMA 50012 BAGNO A RIPOLI, IT


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-26

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