CLINITEK STATUS+ 10379675

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 2020-02-10 for CLINITEK STATUS+ 10379675 manufactured by Siemens Healthcare Diagnostics.

Event Text Entries

[178665979] The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued. Siemens has requested the reagent be returned for investigation. Siemens service reviewed proper technique and cleaning and maintenance procedures. Qc is passing and operators are following proper technique. The customer stated no tests or procedures were delayed due to the discrepant result. The cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10


[178665980] The customer reported a (b)(6) urine hcg result on the clinitek status+ when compared to a repeat on the same instrument, a repeat on another clinitek status+ and a serum quantitative result. There was no reported injury due to this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002637618-2020-00002
MDR Report Key9687788
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-02-10
Date of Report2020-03-27
Date of Event2020-02-06
Date Mfgr Received2020-03-16
Date Added to Maude2020-02-10
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 FDA3
Event Location3
Manufacturer ContactFELIX AKINRINOLA
Manufacturer Street2 EDGEWATER DRIVE
Manufacturer CityNORWOOD, MA
Manufacturer CountryUS
Manufacturer Phone7052212
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 Details

Brand NameCLINITEK STATUS+
Generic NameCLINITEK STATUS+
Product CodeJHI
Date Received2020-02-10
Model Number10379675
Catalog Number10379675
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN, NY US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-10

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