CLINITEK ADVANTUS 10282611

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 2013-04-30 for CLINITEK ADVANTUS 10282611 manufactured by Siemens Healthcare Diagnostics Inc.

Event Text Entries

[3402659] Customer reported a false negative leukocyte on the instrument but the microscopic results were positive. There was no report of injury for this event.
Patient Sequence No: 1, Text Type: D, B5


[10707625] The cause of the discordant leukocyte results is unk.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1217157-2013-00072
MDR Report Key3096513
Report Source07
Date Received2013-04-30
Date of Report2013-04-18
Date of Event2013-04-17
Date Mfgr Received2013-04-18
Date Added to Maude2013-05-13
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 ContactSTEVE ANDBERG
Manufacturer Street2 EDGEWATER DR.
Manufacturer CityNORWOOD MA 02062
Manufacturer CountryUS
Manufacturer Postal02062
Manufacturer Phone7812693655
Manufacturer G1KIMBALL ELECTRONICS POLAND SP.Z.O.O
Manufacturer StreetUL. POZNANSKA 1/C
Manufacturer CityTARNOWO PODGOME 62-080
Manufacturer CountryPL
Manufacturer Postal Code62-080
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLINITEK ADVANTUS
Generic NameCT ADVANTUS
Product CodeCDM
Date Received2013-04-30
Catalog Number10282611
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC
Manufacturer Address511 BENEDICT AVE TARRYTOWN NY 10591 US 10591


Patients

Patient NumberTreatmentOutcomeDate
10 2013-04-30

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