CLINITEK STATUS+ USA 10379675

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-04-10 for CLINITEK STATUS+ USA 10379675 manufactured by Siemens Healthcare Diagnostics.

Event Text Entries

[105421516] The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued. The reagent has been requested to be sent back to siemens for investigation. The cause of the event is unknown.
Patient Sequence No: 1, Text Type: N, H10


[105421517] The customer reported a false negative hcg result on the clinitek status+ and a positive serum beta hcg at the hospital lab. On the same day that the negative hcg results were reported, the patient was given an injection of depo birth control. The patient is pregnant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002637618-2018-00042
MDR Report Key7418102
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2018-04-10
Date of Report2018-04-18
Date of Event2018-03-13
Date Mfgr Received2018-04-17
Date Added to Maude2018-04-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEVEN ANDBERG
Manufacturer Street2 EDGEWATER DRIVE
Manufacturer CityNORWOOD MA 02062
Manufacturer CountryUS
Manufacturer Postal02062
Manufacturer Phone7812693655
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.
Manufacturer StreetNORTHERN ROAD CHILTON INDUSTRIAL ESTATE
Manufacturer CitySUDBURY, CO102XQ
Manufacturer CountryUK
Manufacturer Postal CodeCO10 2XQ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameCLINITEK STATUS+ USA
Generic NameCLINITEK STATUS+
Product CodeLCX
Date Received2018-04-10
Catalog Number10379675
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No0
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591

Device Sequence Number: 1

Brand NameCLINITEK STATUS+ USA
Generic NameCLINITEK STATUS+
Product CodeJIL
Date Received2018-04-10
Catalog Number10379675
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591


Patients

Patient NumberTreatmentOutcomeDate
10 2018-04-10

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