ADVIA CENTAUR XP CALIBRATOR E N/A 10309079

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 2015-12-15 for ADVIA CENTAUR XP CALIBRATOR E N/A 10309079 manufactured by Siemens Healthcare Diagnostics, Inc..

Event Text Entries

[33600332] The cause for the discordant advia centaur xp testosterone results with calibrator lot ce43 is unknown. Siemens healthcare diagnostics is investigating. The instrument is performing within specifications.
Patient Sequence No: 1, Text Type: N, H10


[33600333] Discordant advia centaur xp testosterone results were obtained on samples from eight patients during a lot to lot correlation study for reagent/calibrator (lot 036179 with ce42 and lot 036180 with ce43). A negative bias was observed for patient results. The quality control (qc) was out of range low for level 3 with calibrator ce43. The customer recalibrated with calibrator lot ce42 that was obtained from a sister laboratory. The qc was in range. Three of the patient samples were repeated with reagent lots 036179 and 036180 with calibrator lot ce42. The customer delayed reporting of results until after recalibration and qc was in range. The customer reported results with calibrator lot ce42. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant advia centaur xp testosterone result.
Patient Sequence No: 1, Text Type: D, B5


[38880782] Siemens filed the initial mdr 1219913-2015-00195 on december 15, 2015. 02/03/2016 additional information: siemens performed an internal investigation. Siemens confirmed a lot to lot bias with calibrator e for the advia centaur testosterone assay. The internal investigation demonstrates: an average positive bias of 17% across the assay range with calibrator e kit lots ending in 42 as compared to values generated with the master curve. An average negative bias of 7% across the assay range with calibrator e kit lots ending in 43 as compared to values generated with the master curve. The positive bias of calibrator e kit lots ending in 42 to the master curve compared to the negative bias of calibrator e kit lots ending in 43 to the master curve is the main driver for the negative bias between values generated with calibrator e kit lots ending in 42 and calibrator e kit lots ending in 43. Siemens issued urgent field safety notice cc 16-07. A. Ous and urgent medical device correction cc 16-07. A. Us on february 04, 2016 informing the customer of a lot to lot bias with calibrator e for the advia centaur testosterone assay. Instructions on actions to be taken by the customer are provided in the customer communication. The bias has been resolved with calibrator e kit lots ending in 44. Advia centaur/advia centaur xp/advia centaur xpt testosterone customers should use calibrator e kit lots ending in 44 and above. No further action required.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1219913-2015-00195
MDR Report Key5300706
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2015-12-15
Date of Report2015-11-22
Date of Event2015-11-22
Date Mfgr Received2016-02-03
Device Manufacturer Date2015-07-27
Date Added to Maude2015-12-15
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 ContactMS. EIMAN SULIEMAN
Manufacturer Street333 CONEY STREET
Manufacturer CityEAST WALPOLE MA 02032
Manufacturer CountryUS
Manufacturer Postal02032
Manufacturer Phone5086604603
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Manufacturer Street333 CONEY STREET
Manufacturer CityWALPOLE MA 02032
Manufacturer CountryUS
Manufacturer Postal Code02032
Single Use3
Remedial ActionIN
Previous Use Code3
Removal Correction Number1219913-02/04/2016-002-C
Event Type3
Type of Report3

Device Details

Brand NameADVIA CENTAUR XP CALIBRATOR E
Generic NameCALIBRATOR E
Product CodeJIS
Date Received2015-12-15
Model NumberN/A
Catalog Number10309079
Lot NumberCE43
Device Expiration Date2016-11-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS, INC.
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097


Patients

Patient NumberTreatmentOutcomeDate
10 2015-12-15

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