PATHROMTIN SL 10446066

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-10-26 for PATHROMTIN SL 10446066 manufactured by Siemens Healthcare Diagnostics Product Gmbh.

Event Text Entries

[126513587] The customer contacted siemens customer care center (ccc) to report that discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on one patient sample(s) on a sysmex cs-2500 system. Siemens reviewed the instrument backup files and determined that quality controls (qcs) were within the expected specifications. Siemens identified that maintenance was performed regularly on the system and all inspected kinetics were evaluated correctly by the system software. The cause of the discordant, falsely elevated aptt result is patient's possible medical condition. The instrument is performing according to specifications. No further evaluation of the device is required. Mdr 9610806-2018-00109 was filed for the same event which occurred on (b)(6) 2018. Mdr 9610806-2018-00110 was filed for the same event which occurred on (b)(6) 2018. Mdr 9610806-2018-00111 was filed for the same event which occurred on (b)(6) 2018.
Patient Sequence No: 1, Text Type: N, H10


[126513588] Discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on one patient sample(s) on a sysmex cs-2500 system. The initial discordant result was reported to the physician(s), who questioned the result. Multiple samples from one patient were repeated on the same system, resulting falsely high. The patient was re-drawn and the new sample was run on a non-siemens instrument, resulting lower. The result obtained using the non-siemens methodology was reported, as the correct result to the physician(s). The patient's scheduled arthroscopic surgery was delayed due to the pathological, falsely elevated aptt results and further testing was required. The patient tested negative for factor and lupus anti-coagulants. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610806-2018-00112
MDR Report Key8010829
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-10-26
Date of Report2018-10-26
Date of Event2018-08-23
Date Mfgr Received2018-09-28
Date Added to Maude2018-10-26
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 FDA3
Event Location3
Manufacturer ContactCHRISTINA LAM
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145243504
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH
Manufacturer StreetEMIL-VON-BEHRING-STR 76
Manufacturer CityMARBURG, D-35041
Manufacturer CountryGM
Manufacturer Postal CodeD-35041
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePATHROMTIN SL
Generic NamePATHROMTIN SL
Product CodeGFO
Date Received2018-10-26
Model NumberPATHROMTIN SL
Catalog Number10446066
Lot Number536696A
Device Expiration Date2018-09-25
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH
Manufacturer AddressEMIL-VON-BEHRING-STR 76 MARBURG, D-35041 GM D-35041


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-26

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