PATHROMTIN SL OQGS355 SMN 10446067

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-10 for PATHROMTIN SL OQGS355 SMN 10446067 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[69878382] The cause of the discordant elevated aptt result is unknown. The issue affected the individual sample. Siemens headquarters support center evaluated the information provided. There were no instrument malfunctions identified. The laboratory quality control values were within laboratory ranges. The issue was resolved with repeat testing of the same sample. The incident is likely due to sample pre-analytical handling. The device is operating within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10


[69878383] A discordant elevated activated partial thromboplastin time (aptt) result was obtained on a patient sample on the sysmex cs-5100 instrument. The result was not reported to the physician. The same sample was repeated and a lower result was obtained and reported. There is no indication that patient treatment was altered or prescribed on the basis of the discordant elevated aptt result. There was no report of adverse health consequences as a result of the discordant elevated aptt result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610806-2017-00031
MDR Report Key6394498
Date Received2017-03-10
Date of Report2017-03-10
Date of Event2017-01-27
Date Mfgr Received2017-02-08
Device Manufacturer Date2016-06-14
Date Added to Maude2017-03-10
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 ContactJAMES MORGERA
Manufacturer StreetGLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal197146101
Manufacturer Phone3026318356
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer StreetEMIL VON BEHRING STRASSE 76
Manufacturer CityMARBURG, D-35041
Manufacturer CountryGM
Manufacturer Postal CodeD-35041
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePATHROMTIN SL
Generic NamePATHROMTIN SL
Product CodeGFO
Date Received2017-03-10
Catalog NumberOQGS355 SMN 10446067
Lot Number536690B
Device Expiration Date2018-01-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer AddressEMIL VON BEHRING STRASSE 76 MARBURG, D-35041 GM D-35041


Patients

Patient NumberTreatmentOutcomeDate
10 2017-03-10

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