NEG URINE COMBO 73 N/A B1017-423

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 NEG URINE COMBO 73 N/A B1017-423 manufactured by Beckman Coulter.

Event Text Entries

[21192908] It was reported that upon initial test of (b)(6) survey isolate an identification of leminorella sp 93. 14% was obtained. Repeat testing was performed after a couple of days and the same identification was obtained. Upon notification from (b)(6) of the incorrect result repeat tests were performed and the same leminorella sp. Identification was obtained. It was reported that the panel qc was within specification for all panel set ups. Customer stated that panel results from walkaway instrument were visually confirmed and were correct. 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


[21505962] 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 2919016-2015-00037, 2919016-2015-00038 and 2919016-2015-00040 for report of a similar event. Beckman coulter internal identifier for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2919016-2015-00039
MDR Report Key4776036
Report Source05,06
Date Received2015-05-15
Date of Report2015-04-15
Date of Event2015-04-11
Date Mfgr Received2015-04-15
Device Manufacturer Date2015-01-29
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 NameNEG URINE COMBO 73
Generic NameMICRO DILUTION PANEL
Product CodeLRG
Date Received2015-05-15
Model NumberN/A
Catalog NumberB1017-423
Lot Number2016-01-29
Device Expiration Date2016-01-29
Device AvailabilityN
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 2015-05-15

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