ADVIA 120 067-A004-13

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 2012-04-19 for ADVIA 120 067-A004-13 manufactured by Siemens Healthcare Diagnostics.

Event Text Entries

[16434242] A discordant advia 120 hemaglobin ( hgb) result was obtained on a patient sample. The result was reported to the physician. The laboratory repeated the sample and a new sample was redrawn and tested. The corrected result was reported to the physician. The nursing home patient was sent to the hospital. There are no known reports of adverse health consequences due to the discordant hgb result.
Patient Sequence No: 1, Text Type: D, B5


[16627218] A siemens field service engineer ( fse) evaluated the advia 120 instrument and instrument data. The fse flushed all the pathways. Replaced the rbc sample syringe and the flowcell tubing, refocused the laser with optipoint and adjusted the gains accordingly, ran qc. The system is operational. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2432235-2012-00127
MDR Report Key2540335
Report Source05,06
Date Received2012-04-19
Date of Report2012-04-09
Date of Event2012-04-04
Date Mfgr Received2012-04-09
Device Manufacturer Date2004-01-06
Date Added to Maude2012-09-12
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 ContactELIZABETH BEATO
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145243074
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS
Manufacturer StreetMANUFACTURING LIMITED CHAPEL LANE
Manufacturer CitySWORD, CO DUBLIN
Manufacturer CountryEI
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADVIA 120
Generic NameHEMATOLOGY ANALYZER
Product CodeGKL
Date Received2012-04-19
Model NumberADVIA 120
Catalog Number067-A004-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS
Manufacturer Address511 BENEDICT AVE TARRYTOWN NY 10591 US 10591


Patients

Patient NumberTreatmentOutcomeDate
10 2012-04-19

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