ADVIA CHEMISTRY XPT

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 2017-09-21 for ADVIA CHEMISTRY XPT manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[88070838] The customer contacted the siemens customer care center (ccc). The customer ran quality controls, resulting with error flags. A siemens customer service engineer (cse) was at the customer site. After inspecting the instrument, the cse replaced the reagent probe 2 mix paddle, solenoid reagent probe valve 2, and lamp. The cse checked all valves. The customer ran quality control (qc), resulting acceptable. The cause of the discordant, falsely elevated po4 result is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10


[88070839] A discordant, falsely elevated inorganic phosphorus (po4) result was obtained on a patient sample on an advia chemistry xpt instrument. The discordant result was not reported to the physician(s). The sample was repeated on an alternate instrument, resulting lower. The repeated result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant falsely elevated po4 result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2432235-2017-00519
MDR Report Key6884309
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-09-21
Date of Report2017-09-21
Date of Event2017-08-27
Date Mfgr Received2017-08-29
Device Manufacturer Date2015-06-10
Date Added to Maude2017-09-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. MARGARITA KARAN
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145243105
Manufacturer G1JEOL LTD
Manufacturer StreetREGISTRATION NUMBER: 300363768 3-1-2 MUSASHINO AKISHIMA
Manufacturer CityTOKYO 196-8558,
Manufacturer CountryJA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameADVIA CHEMISTRY XPT
Generic NameADVIA CHEMISTRY XPT
Product CodeCEO
Date Received2017-09-21
Model NumberADVIA CHEMISTRY XPT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No0
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591

Device Sequence Number: 1

Brand NameADVIA CHEMISTRY XPT
Generic NameADVIA CHEMISTRY XPT
Product CodeJJE
Date Received2017-09-21
Model NumberADVIA CHEMISTRY XPT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591


Patients

Patient NumberTreatmentOutcomeDate
10 2017-09-21

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