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 07 report with the FDA on 2015-03-13 for NEG URINE COMBO 73 N/A B1017-423 manufactured by Beckman Coulter.

Event Text Entries

[5698108] The manufacturer service support-sacramento assays department reported that there was an identification discrepancy when testing the college of american pathologist (cap) survey isolate d-04 2015. The isolate was identified as leminorella on the walkaway (wa) 96 si instrument and shigella when read on the autoscan-4 (as-4) instrument. There was no patient involved as this was a proficiency survey isolate.
Patient Sequence No: 1, Text Type: D, B5


[13054481] In addition, the cap survey isolate was tested on rapid neg id 3 (rnid3) panel, and rapid neg id 4 (rnid4) panel. The sample was also tested on an analytical profile index (api) strip as a reference test method. A high probability id shigella was attained on both of the rapid negative panels. On the api strip, a low probability id of shigella sp. Was attained. The cap survey final report has not been finalized for this isolate, the correct id of the specimen cannot be determined at this time. Please refer to medwatch report number 2919016-2015-00007 for a report of a similar event which occurred on (b)(6) 2015. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[30231638] 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 Number2919016-2015-00006
MDR Report Key4601642
Report Source07
Date Received2015-03-13
Date of Report2015-02-12
Date of Event2015-02-10
Date Mfgr Received2015-03-26
Device Manufacturer Date2014-03-11
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
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 URINE COMBO 73
Generic NameMICRO DILUTION PANEL
Product CodeLTT
Date Received2015-03-13
Model NumberN/A
Catalog NumberB1017-423
Lot Number2015-03-11
Device Expiration Date2015-03-11
OperatorOTHER
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.