CLINITEK STATUS 10332185

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-04-11 for CLINITEK STATUS 10332185 manufactured by Siemens Healthcare Diagnostics.

Event Text Entries

[105648018] The customer stated that repeat testing was performed to confirm correct results which met the medical opinion and a corrected report was issued. Siemens reviewed cleaning, maintenance and proper technique for testing, with the customer. The customer was not cleaning the calibration bar. The qc is now in the expected ranges.
Patient Sequence No: 1, Text Type: N, H10


[105648019] The customer reported a false negative urine hcg on the clinitek status and positive serum quant. Hcg on another lab analyzer (unknown). There is no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002637618-2018-00044
MDR Report Key7422171
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2018-04-11
Date of Report2018-04-11
Date of Event2018-03-27
Date Mfgr Received2018-03-30
Date Added to Maude2018-04-11
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
Generic NameCLINITEK STATUS
Product CodeLCX
Date Received2018-04-11
Catalog Number10332185
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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
Generic NameCLINITEK STATUS
Product CodeKQO
Date Received2018-04-11
Catalog Number10332185
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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 2018-04-11

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