PFA COLLAGEN/EPI 10445696

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 2019-12-11 for PFA COLLAGEN/EPI 10445696 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[175423630] The customer contacted a siemens customer care center (ccc) and reported that discordant, falsely low platelet function assay (pfa) - epinephrine (epi) results were obtained on eleven patient samples on an innovance pfa-200 system using pfa collagen/epi reagent. The customer's innovance pfa-200 system had previously been replaced and the vacuum chuck of the innovance pfa-200 system was cleaned, but the issue is still occurring. Mdrs 9610806-2019-00091, 9610806-2019-00093, 9610806-2019-00094, and 9610806-2019-00095 were also filed for the four other dates when the discordant results were obtained. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10


[175423631] Discordant, falsely low platelet function assay (pfa) - epinephrine (epi) results were obtained on eleven patient samples on an innovance pfa-200 system using pfa collagen/epi reagent. The results were reported to the physician(s) and were questioned by the physician(s) as the patients were all taking 100 mg of aspirin. There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low platelet function assay (pfa) - collagen epinephrine (col/epi) results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610806-2019-00092
MDR Report Key9452062
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-12-11
Date of Report2020-02-07
Date of Event2019-11-12
Date Mfgr Received2020-01-20
Date Added to Maude2019-12-11
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 ContactCHRISTOPHER AEBIG
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242740
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS 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 NamePFA COLLAGEN/EPI
Generic NamePFA COLLAGEN/EPI
Product CodeJOZ
Date Received2019-12-11
Model NumberPFA COLLAGEN/EPI
Catalog Number10445696
Lot Number5695476
Device Expiration Date2019-02-19
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer AddressEMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-11

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