CLINITEK STATUS ANALYZER CT STATUS

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 2011-06-30 for CLINITEK STATUS ANALYZER CT STATUS manufactured by Siemens Healthcare Diagnostics, Manufacturing Ltd..

Event Text Entries

[2130131] Customer reports a false positive urine hcg on a patient. Repeat testing on same sample was negative. No unnecessary medical procedure was performed. No treatment was withheld as a result of this incident. There was no impact to patient health.
Patient Sequence No: 1, Text Type: D, B5


[9147273] Instrument returned to manufacturer for investigation. Service personnel observed debris inside instrument and optics out of alignment. Customer is using replacement instrument.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1217157-2011-00020
MDR Report Key2192575
Report Source07
Date Received2011-06-30
Date of Report2011-06-03
Date of Event2011-06-03
Date Mfgr Received2011-06-03
Device Manufacturer Date2008-01-01
Date Added to Maude2012-05-15
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 ContactMARK SMITH
Manufacturer Street2 EDGEWATER DR.
Manufacturer CityNORWOOD MA 02062
Manufacturer CountryUS
Manufacturer Postal02062
Manufacturer Phone7812693158
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.
Manufacturer StreetNORTHERN ROAD
Manufacturer CitySUDBURY, SUFFOLK 02062CO1
Manufacturer CountryUK
Manufacturer Postal Code02062 CO10
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLINITEK STATUS ANALYZER
Generic NameCLINITEK STATUS ANALYZER
Product CodeLCX
Date Received2011-06-30
Model NumberCT STATUS
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.
Manufacturer AddressNORTHERN ROAD SUDBURY, SUFFOLK CO106DX UK CO10 6DX


Patients

Patient NumberTreatmentOutcomeDate
10 2011-06-30

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