SYVA? EMIT 6X019UL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-09-27 for SYVA? EMIT 6X019UL manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.

Event Text Entries

[2907431] Imprecise amikacin results were obtained on a patient sample. It is unknown if the patient result was reported to the physician. It is unknown if patient treatment was altered or prescribed. There is no report of adverse outcome to the patient as a result of imprecise amikacin results.
Patient Sequence No: 1, Text Type: D, B5


[10139362] Analysis of the instrument and instrument data indicate that the cause for the imprecise amikacin results is unknown. Xamik is an open channel reagent (i. E. Flex prepared by customer). The dimension vista instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2517506-2012-00255
MDR Report Key2763505
Report Source01,05,06
Date Received2012-09-27
Date of Report2012-07-05
Date of Event2012-06-29
Date Mfgr Received2012-07-05
Device Manufacturer Date2011-09-01
Date Added to Maude2013-01-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJAMES MORGERA
Manufacturer StreetGLASGOW BUSINESS COMMUNITY PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal197146101
Manufacturer Phone3026318356
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
Manufacturer StreetGLASGOW BUSINESS COMMUNITY 500 GBC DRIVE
Manufacturer CityNEWARK DE 19702
Manufacturer CountryUS
Manufacturer Postal Code19702
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYVA? EMIT
Generic NameSYVA? EMIT AMIKACIN ASSAY
Product CodeKLQ
Date Received2012-09-27
Catalog Number6X019UL
Lot NumberD2
Device Expiration Date2014-08-31
OperatorMEDICAL TECHNOLOGIST
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
Manufacturer AddressGLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19702 US 19702


Patients

Patient NumberTreatmentOutcomeDate
10 2012-09-27

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