CHROMID? STREPTO B AGAR 43461

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 2017-11-01 for CHROMID? STREPTO B AGAR 43461 manufactured by Biomerieux Sa.

Event Text Entries

[91932910] A customer from (b)(6) notified biom? Rieux of discrepant results when testing a quality control sample using chromid? Strepto b agar (reference 43461). The customer reported that they repeated the quality control test using the same quality control sample and their second lot of chromid? Strepto b agar reference 43461 and had obtained the same discrepant result. This second event has been recorded under (b)(4). The customer stated that they had inoculated strep. Agalactiae atcc 13813 quality control sample directly in the agar plates and that after 18-24 hours incubation under co2, they had observed the expected characteristic bacterial growth (red colonies). The customer reported that in parallel they had directly inoculated in the same plates e. Coli atcc 25922 as a negative quality control sample and that after 18-24 hour incubation under co2, they had observed unexpected bacterial growth of red colonies on both lots. The customer said that they had discarded all their inventory of the concerned product and that patients' samples' were not tested on these two lots. The customer mentioned that the issue has been observed only on these two new product lots and that the expected negative results were obtained when testing previous lot number of the chromid? Strepto b agar reference 43461 with the same e. Coli atcc 25922 quality control sample. There is no indication or report from the customer to biom? Rieux that the discrepant results led to any adverse event related to any patient's state of health. The quality control sample results are not directly associated with any patient. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002769706-2017-00327
MDR Report Key6993848
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-11-01
Date of Report2018-03-12
Date Mfgr Received2017-11-22
Device Manufacturer Date2017-08-29
Date Added to Maude2017-11-01
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 ContactMS. ELLEN WELTMER
Manufacturer Street595 ANGLUM ROAD
Manufacturer CitySAINT LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1BIOMERIEUX SA
Manufacturer Street5, RUE DES AQUEDUCS CRAPONNE, FR 69290
Manufacturer CountryFR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHROMID? STREPTO B AGAR
Generic NameCHROMID? STREPTO B AGAR
Product CodePQZ
Date Received2017-11-01
Catalog Number43461
Lot Number1005925100
Device Expiration Date2017-12-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX SA
Manufacturer Address5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-01

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