OVERNIGHT CONVENTIONAL GRAM NEGATIVE NUC66 PANEL N/A B1016-171

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 2015-05-15 for OVERNIGHT CONVENTIONAL GRAM NEGATIVE NUC66 PANEL N/A B1016-171 manufactured by Beckman Coulter.

Event Text Entries

[17212855] It was reported that the (b)(6) survey isolate was initially tested twice and an identification of leminorella sp 93. 14% was obtained. Upon notification from cap of the incorrect result, it was reported that the customer reran the isolate from the original blood agar plate (bap) and obtained shigella sp. Customer stated they did not do anything different between the two runs as far as method. Qc was in range during testing of specimen. The correct identification of the isolate was shigella boydii per (b)(6) bacteriology participant summary report. There was no patient involved as this was a proficiency survey.
Patient Sequence No: 1, Text Type: D, B5


[17443185] The manufacturer participated in the same proficiency survey using (b)(6) 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 (cephalothin 8 (ug/ml) 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. The results from the cf8 panel along with the panel results from the other biochemicals/antimicrobics are used to generate the biotype number for the organism tested and the corresponding identification. 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 and a low probability id of shigella sp. Was attained. It is possible that emerging resistance with this organism may be contributing to the identification discrepancy. Please refer to medwatch report number 2919016-2015-00046 for report of a similar event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2919016-2015-00047
MDR Report Key4776012
Report Source05,06
Date Received2015-05-15
Date of Report2015-04-16
Date of Event2015-02-12
Date Mfgr Received2015-04-16
Date Added to Maude2015-06-16
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
Event Type3
Type of Report3

Device Details

Brand NameOVERNIGHT CONVENTIONAL GRAM NEGATIVE NUC66 PANEL
Generic NameMICRO DILUTION PANEL
Product CodeLRG
Date Received2015-05-15
Model NumberN/A
Catalog NumberB1016-171
Lot NumberNOT PROVIDED
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER
Manufacturer Address2040 ENTERPRISE BLVD WEST SACRAMENTO CA 95691 US 95691


Patients

Patient NumberTreatmentOutcomeDate
10 2015-05-15

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