CHROMID(TM) OXA 414011

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 2016-03-28 for CHROMID(TM) OXA 414011 manufactured by Biom?rieux Sa.

Event Text Entries

[41263132] A customer in (b)(6) reported no growth of klebsiella pneumoniae oxa 232 on 3 lots while using; chromid(tm) oxa. The customer repeated the test on three times with the same result; a growth on chromid esbl but no growth on chromid(tm) oxa 48 20 plts. The final two tests were performed with an enrichment with 2 discs and obtained the same result of; esbl: positive, oxa: negative. This klebsiella pneumonia strain was confirmed as resistant to temocillin (mic=384 micro-g/m)l. This strain was identified as; klebsiella pneumoniae oxa 232. There were no reports of patient harm or delay in results.
Patient Sequence No: 1, Text Type: D, B5


[50139552] A customer in france reported a false susceptible result of klebsiella pneumonia oxa 232 on 3 lots while using chromid? Oxa. An internal biom? Rieux investigation was performed. Results are as follows: false negative result with the customer strain klebsiella pneumonia as on two (2) other lots close to the same expiration date(13 weeks). The result is well positive on lots more recent(=1024 including the macro colonies in the inhibition zone. There was also an ellipse observed to 256mg/l so the expression of the resistance was heterogeneous. Complaint history: complaint history was reviewed with no trends noted. In conclusion, the false negative result is duplicated in-house and the media chromid? Oxa 48 lot 1004624570 and 1004554440. The sensitivity of this medium has been fixed at 95% (see package insert). This is isolated issue. The device is operating within product limitations (sensitivity 95%).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3002769706-2016-00059
MDR Report Key5529008
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2016-03-28
Date of Report2016-03-10
Date Mfgr Received2016-03-10
Device Manufacturer Date2016-02-15
Date Added to Maude2016-03-28
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 ContactMR. JONATHAN NONNEMACHER
Manufacturer Street100 RODOLPHE STREET
Manufacturer CityDURHAM NC 27712
Manufacturer CountryUS
Manufacturer Postal27712
Manufacturer Phone9196203396
Manufacturer G1BIOM
Manufacturer Street5, RUE DES AQUEDUCS
Manufacturer CityCRAPONNE, FR 69290
Manufacturer CountryFR
Manufacturer Postal Code69290
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHROMID(TM) OXA
Generic NameCHROMID(TM) OXA
Product CodeJXA
Date Received2016-03-28
Catalog Number414011
Lot Number1004658460
Device Expiration Date2016-05-21
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBIOM?RIEUX SA
Manufacturer Address5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR 69290


Patients

Patient NumberTreatmentOutcomeDate
10 2016-03-28

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