VIDAS? CMV IGM 30205

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 2017-09-06 for VIDAS? CMV IGM 30205 manufactured by Biomerieux, S.a..

Event Text Entries

[86581434] A biom? Rieux internal investigation was performed. A customer reported low results when testing the iqc "virotrol" from biorad with idas cmv igm lot 1005685430(1. 61 vt, 0. 96 vt, 1. 04 vt, 1. 11 vt and 1. 01 vt) compared to the specification the customer put in place based on results obtained on previous lots. A review of quality records confirmed there was no issue in the production of lot 10056854301. An analysis of the control chart for 5 internal samples (target : 1. 84 - 1. 27 - 2. 08 - 1. 07 - 0. 31 tv) on 9 different batches of vidas cmvm, showed that vidas cmv igm lot 1005685430/180320-0 was in the trend of the other batches. The quality product laboratory tested these 5 internal samples on the retained kit of vidas cmv igm lot 1005685430 and obtained the following results : cm34 : 1. 70 tv; cm26 : 1. 13 tv; cm29 : 1. 86 tv ; cm104 0. 85 tv; cm15 : 0. 29 tv. All the results were within the specifications and similar to those obtained before the release of the batch vidas cmv igm lot 1005685430. There was no drift of lot 1005685430. The quality product laboratory had tested the iqc biorad virotrol with the vidas cmvm lot 180320-0 (retain kit) and lot 171203-0 (reference kit). The results were positive with the 2 batches. Batch 171203-0: 1. 43 tv. Batch 180320-0: 1. 04 tv. The differences observed are linked to the normal inter-lot variability which has no impact on patient result or interpretation status. The iqc virotrol is manufactured (not natural sample) and manufacturing process can affect sample matrix, so the hypothesis is that this sample could behave differently following some lots of vidas cmvm. It is recommended that each laboratory establishes its own range for each analyte (extract from package insert virotrol torch-m). The quality product laboratory recomputed the following range based on the customer's data (3 discrepant values out of 96 values not taken into account because visibly out of trend 3. 32tv, 3. 54 tv, 2. 19 tv) : mean : 1. 485 tv. 2et : [1. 164-1. 806] tv. 3et : [1. 003-1. 967] tv. According to this new statistics, customer's values excluding 3 discrepant values conform within range at 3 et (except for one value at 0,96 vt). Check with the customer how statistics are computed and suggest the customer that is also possible to work with a mobile mean. Quality product laboratory analyzed complaints about sensitivity problem (potential false negative result) since 2013 and observed that there is no increase of complaints. Based on complaints, the relative sensitivity is about 99. 99 % and conform to package insert performances (sensitivity: 90. 24 %). According to the data mentioned above, vidas cmv igm lot 1005685430/180320-0 is within the expected specifications.
Patient Sequence No: 1, Text Type: N, H10


[86581435] A customer from (b)(6) reported to biom? Rieux out of range results when testing the internal quality control virotrol from bio-rad in association with vidas? Cmv igm (lot 1005685430). The test results were: (b)(6) 2017: s1 1342/1019 rfv [714-1548]; c1 1477 rfv 1. 25 [1. 12-1. 6]; c2 -4 rfv 0. 00 Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002769706-2017-00268
MDR Report Key6844482
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-09-06
Date of Report2018-07-16
Date of Event2017-06-22
Date Mfgr Received2018-06-20
Device Manufacturer Date2017-05-15
Date Added to Maude2017-09-06
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 ContactMRS. ELLEN WELTMER
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityST. LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147317301
Manufacturer G1BIOMERIEUX, S.A.
Manufacturer StreetCHEMIN DE L ORME
Manufacturer CityMARCY L ETOILE, RHONE 69280
Manufacturer CountryFR
Manufacturer Postal Code69280
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVIDAS? CMV IGM
Generic NameVIDAS? CMV IGM
Product CodeLKQ
Date Received2017-09-06
Catalog Number30205
Lot Number1005685430
ID Number03573026064396
Device Expiration Date2018-03-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, S.A.
Manufacturer AddressCHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280


Patients

Patient NumberTreatmentOutcomeDate
10 2017-09-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.