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 2011-12-09 for CLINITEK STATUS+ ANALYZER CT STATUS+ manufactured by Siemens Healthcare Diagnostics, Manufacturing Ltd..

Event Text Entries

[2568779] False negative hcg reported for clinitest hcg. No injury or harm to patient was reported. No serum sample run. Patient mammogram cancelled.
Patient Sequence No: 1, Text Type: D, B5


[9534643] Patient came to facility and reported a positive home pregnancy result. Technician tested the patient using a manual unknown method with a result of "faint positive". Facility reported that controls were run after the clinitest negative result and controls were acceptable. Repeat sample on clinitek status result positive.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1217157-2011-00045
MDR Report Key2414762
Report Source07
Date Received2011-12-09
Date of Report2011-10-20
Date of Event2011-10-20
Date Mfgr Received2011-10-20
Date Added to Maude2012-07-23
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 ContactMARK SMITH
Manufacturer Street2 EDGEWATER DR.
Manufacturer CityNORWOOD MA 02062
Manufacturer CountryUS
Manufacturer Postal02062
Manufacturer Phone7812693158
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.
Manufacturer StreetNORTHERN RD.
Manufacturer CitySUDBURY, SUFFOLK CO102XQ
Manufacturer CountryUK
Manufacturer Postal CodeCO10 2XQ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLINITEK STATUS+ ANALYZER
Generic NameCLINITEK STATUS+ ANALYZER
Product CodeLCX
Date Received2011-12-09
Model NumberCT STATUS+
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.
Manufacturer AddressNORTHERN RD. SUDBURY, SUFFOLK CO106DX UK CO10 6DX


Patients

Patient NumberTreatmentOutcomeDate
10 2011-12-09

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