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 2011-06-24 for CLINITEK STATUS ANALYZER CT STATUS manufactured by Siemens Medical Solutions Diagnostics, Ltd..

Event Text Entries

[2122778] Customer reported two false negative hcg result on the same patient sample on two different clinitek status instruments using lot 028619 reagent. Result was reported to the physician. Pregnancy was subsequently confirmed using ultrasound. The patient's treatment was not affected by the urine test result. No treatment was provided or denied prior to the ultrasound test.
Patient Sequence No: 1, Text Type: D, B5


[9244407] Manufacturer was unable to confirm false negative results using lot 028619. Customer states that quality control is performed daily on instruments and customer is currently using the instruments.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1217157-2011-00018
MDR Report Key2176027
Report Source07
Date Received2011-06-24
Date of Report2011-05-27
Date of Event2011-05-27
Date Mfgr Received2011-05-27
Device Manufacturer Date2011-01-01
Date Added to Maude2011-12-23
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 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 Received2011-06-24
Model NumberCT STATUS
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.
Manufacturer AddressNORTHERN ROAD SUDBURY, SUFFOLK CO106DX UK CO10 6DX


Patients

Patient NumberTreatmentOutcomeDate
10 2011-06-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.