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 2019-12-18 for EASYMAG? INSTRUMENT - 200111 manufactured by Biomerieux Sa.

Event Text Entries

[188091728] The device was not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[188091729] A customer from (b)(6) notified biomerieux of a contamination issue leading to false positive results and an overestimated result for polyoma bk virus result in association with the easymag? Instrument (ref. 200111, serial (b)(4)). The customer reported a patient? S urine sample containing high dose of polyoma bk virus has cross- contaminated four separate patient samples (serum samples) also being tested for polyoma bk. The customer confirmed the four patients were grafted male patients hospitalized at the time of the testing, and taking immunosuppressive therapy. The contamination resulted in false positive polyoma bk virus results for three patient samples. These three patients were retested two weeks later using the easymag? And all obtained negative results for polyoma bk virus. The customer confirmed one patient sample result was falsely overestimated for polyoma bk virus due to the contamination. This patient was confirmed positive by re-testing performed two weeks later. The customer stated for the three polyoma bk virus negative patients, the false positive results led to change of immunosuppressive drug dosage; therapy management for the fourth patient was not reported. Biomerieux will initiate an internal investigation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615037-2019-00043
MDR Report Key9490273
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-12-18
Date of Report2020-03-10
Date Mfgr Received2020-02-11
Date Added to Maude2019-12-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJENNIFER ARMSTRONG
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145068201
Manufacturer G1BIOMERIEUX ITALIA S.P.A.
Manufacturer StreetVIA DI CAMPIGLIANO 58 / LOC. P 50012 BAGNO A RIPOLI
Manufacturer CityFIRENZE
Manufacturer CountryIT
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEASYMAG? INSTRUMENT - 200111
Generic NameEASYMAG? INSTRUMENT - 200111
Product CodeJJH
Date Received2019-12-18
Model Number200111
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX SA
Manufacturer Address58 - LOC. PONTE A EMA 50012 BAGNO A RIPOLI FIRENZE IT


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-18

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