PFA-100 SYSTEM 10444868

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-07-16 for PFA-100 SYSTEM 10444868 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[114011656] The customer contacted a siemens customer care center (ccc) and reported that they obtained elevated col/epi and col/adp results on patient samples and quality controls (qcs). The customer indicated that the error message "maximum test time exceeded" was triggered by the system. The customer reported an incident where they obtained different results on control donors, depending on the cuvette position used to process the sample. Siemens is investigating the issue. Mdrs 9610806-2018-00058, 9610806-2018-00059, 9610806-2018-00060, 9610806-2018-00061, 9610806-2018-00062, 9610806-2018-00063, 9610806-2018-00064, 9610806-2018-00065, 9610806-2018-00066, 9610806-2018-00067, 9610806-2018-00069, 9610806-2018-00070, 9610806-2018-00071, 9610806-2018-00072, and 9610806-2018-00073 were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10


[114011657] The customer reported that elevated collagen/ epinephrine (col/epi) and collagen/ adenosine-5'-diphosphate (col/adp) results were obtained on multiple patient samples on the pfa-100 system for several days. The elevated results were reported to the physician(s) and some physician(s) questioned the elevated results. It is unknown if the results provided by the customer were discordant and the results reported to the physician(s) are unknown. The customer did not provide the correct results for the patients impacted and reported that they did not provide correct results to the physician(s). There are no known reports of patient intervention or adverse health consequences due to elevated col/epi and col/adp results obtained on the patient samples.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610806-2018-00068
MDR Report Key7689195
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-07-16
Date of Report2018-08-07
Date of Event2018-06-04
Date Mfgr Received2018-07-12
Date Added to Maude2018-07-16
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 G1BIT ANALYTICAL INSTRUMENTS GMBH
Manufacturer StreetREGISTRATION NUMBER:3003601075 AM KRONBERGER HANG 3
Manufacturer CitySCHWALBACH 65824
Manufacturer CountryGM
Manufacturer Postal Code65824
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePFA-100 SYSTEM
Generic NamePFA-100 SYSTEM
Product CodeJOZ
Date Received2018-07-16
Model NumberPFA-100 SYSTEM
Catalog Number10444868
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 2018-07-16

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