NEG BREAKPOINT COMBO 47 N/A B1017-417

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-13 for NEG BREAKPOINT COMBO 47 N/A B1017-417 manufactured by Beckman Coulter.

Event Text Entries

[5698590] The customer reported obtaining two different biotypes for the non-lactose fermenter organism in a proficiency survey stool specimen on the walkaway (wa) 40si instrument using negative breakpoint combo 47 panel type. The isolate in question was identified as d-04 2015 cap survey isolate. Identification (id) of leminorella sp. 93. 14% on initial test and upon retest, shigella sp. 99. 30% was attained. The only difference reported between the two panels was the cephalothin (cf8) well, which was positive on the initial test and negative on the repeat panel. Another repeat, date was unknown but believed to be on or around (b)(6) 2015 resulted in an id of leminorella 93% there was no patient involved as this was a proficiency survey isolate.
Patient Sequence No: 1, Text Type: D, B5


[13004269] The manufacturer participated in the same proficiency survey using d-04 2015 cap survey isolate. When tested on conventional overnight panels and read on the wa instrument, an id of leminorella sp. 93. 14% was attained. When the same panel was read on the autoscan-4 (as-4) instrument, an id of shigella sp. 99. 30% was attained. The difference between the two reads was the cf8 well; the cf8 well was negative on the wa and positive on the as-4. It was noted that the cf8 well was a weak positive when visually verified. An id of shigella was also attained on two additional tests using rapid negative panels. Also, the sample was tested on an analytical profile index (api) strip as a reference test method. A low probability id of shigella sp. Was attained. Please refer to medwatch report number 2919016-2015-00008 for a report of a similar event which occurred on (b)(6) 2015. Mdr numbers 2919016-2015-00006 and 2919016-2015-00007 were filed for the id discrepancy observed during internal testing. The cap proficiency survey report is still outstanding for this isolate, therefore unable to confirm correct id of the organism. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[30231639] The cap survey was received confirming the identification of the(b)(6) isolate as shigella boydii.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2919016-2015-00009
MDR Report Key4601662
Report Source05,06
Date Received2015-03-13
Date of Report2015-02-25
Date of Event2015-02-25
Date Mfgr Received2015-03-26
Device Manufacturer Date2014-11-14
Date Added to Maude2015-04-15
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 FDA0
Event Location0
Manufacturer ContactNORMA RAHILL
Manufacturer Street1584 ENTERPRISE BLVD
Manufacturer CityWEST SACRAMENTO CA 95691
Manufacturer CountryUS
Manufacturer Postal95691
Manufacturer Phone9163742139
Manufacturer G1BECKMAN COULTER
Manufacturer Street2040 ENTERPRISE BLVD
Manufacturer CityWEST SACRAMENTO CA 95691
Manufacturer CountryUS
Manufacturer Postal Code95691
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameNEG BREAKPOINT COMBO 47
Generic NameMICRO DILUTION PANEL
Product CodeLTT
Date Received2015-03-13
Model NumberN/A
Catalog NumberB1017-417
Lot Number2015-11-14
Device Expiration Date2015-11-14
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER
Manufacturer Address2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US 95691


Patients

Patient NumberTreatmentOutcomeDate
10 2015-03-13

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