NEG BREAKPOINT COMBO 41 N/A B1017-408

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 2015-05-20 for NEG BREAKPOINT COMBO 41 N/A B1017-408 manufactured by Beckman Coulter.

Event Text Entries

[5853886] It was reported that the (b)(6) was tested two times and identified the isolate as leminorella sp. 93. 14%. Upon notification from (b)(6) of the incorrect result, repeat test was performed and obtained the same identification of leminorella species. It was reported that the qc was within range before and after the reported misidentification. The correct id of the isolate was shigella boydii per 2015 (b)(6) d-a bacteriology participant summary report. There was no patient involved as this was a proficiency survey.
Patient Sequence No: 1, Text Type: D, B5


[13331846] The manufacturer participated in the same proficiency survey using (b)(6). 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 numbers 2919016-2015-00052 and 2919016-2015-00053 for reports of similar event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2919016-2015-00051
MDR Report Key4785373
Report Source05,06
Date Received2015-05-20
Date of Report2015-04-22
Date of Event2015-02-10
Date Mfgr Received2015-04-22
Date Added to Maude2015-06-19
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 BREAKPOINT COMBO 41
Generic NameMICRO DILUTION PANEL
Product CodeLRG
Date Received2015-05-20
Model NumberN/A
Catalog NumberB1017-408
Lot NumberNOT PROVIDED
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 2015-05-20

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