THERMO SCIENTIFIC? TCAUTOMATION? 952040

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-25 for THERMO SCIENTIFIC? TCAUTOMATION? 952040 manufactured by Thermo Fisher Scientific Oy.

Event Text Entries

[109886563] Based on the investigation results the it was determined that after the tube for sample a was placed in the centrifuge module load rack, the operator stopped the centrifuge module but did not remove all the samples as required per the instructions in the user manual. The operator then started the centrifuge module by releasing the module lock but did not remove all the samples prior to releasing the module lock as required per the instructions in the user manual. The tcautomation software performed as designed by correctly identifying the sample identification (sid) mismatch by posting a cross check error message. The results of the investigation did not identify any failures with the system.
Patient Sequence No: 1, Text Type: N, H10


[109886564] A customer reported that test results from a patient sample processed on the thermo scientific? Tcautomation? Laboratory automation system were mis-associated with the sample identification number (sid) of a different patient. Mis-associated patient results may lead to inappropriate physician action. The mis-associated patient test result was reported from the laboratory. There is no allegation of patient harm as a result of this event. The tcautomation software correctly identified the sid mismatch by posting a cross check failure message, as designed. This report corresponds to thermo fisher scientific (b)(4) complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610942-2018-00001
MDR Report Key7543821
Date Received2018-05-25
Date of Report2018-05-25
Date of Event2018-04-18
Date Mfgr Received2018-04-27
Device Manufacturer Date2017-09-01
Date Added to Maude2018-05-25
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 ContactANNIKA ASTOLA
Manufacturer StreetRATASTIE 2
Manufacturer CityVANTAA, 01620
Manufacturer CountryFI
Manufacturer Postal01620
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTHERMO SCIENTIFIC? TCAUTOMATION?
Generic NameLABORATORY AUTOMATION SYSTEM
Product CodeLXG
Date Received2018-05-25
Catalog Number952040
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTHERMO FISHER SCIENTIFIC OY
Manufacturer AddressRATASTIE 2 VANTAA, 01620 FI 01620


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-25

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