DIMENSION VISTA? K6451 SMN 10445090

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 2018-04-11 for DIMENSION VISTA? K6451 SMN 10445090 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[105399640] Mdrs 2517506-2018-00219, 2517506-2018-00220, and 2517506-2018-00222 were filed for the same customer inquiry. The customer contacted siemens customer care center (ccc) and reported that a discordant, falsely elevated tpsa patient result was obtained on the dimension vista system. The customer confirmed that there have been no issues with quality control (qc) and all survey results were good. Siemens headquarters support center (hsc) evaluated the information provided by the customer including information the customer provided on results on a later date sample when treated with a heterophile antibody blocking tube. The cause of the discordant, falsely elevated tpsa patient result is unknown. Hsc noted that the results are consistent with a heterophilic antibody interference as indicated in the dimension vista tpsa instructions for use.. The dimension vista? Tpsa total prostate specific antigen flex? Reagent cartridge instructions states: patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. This assay has been designed to minimize interference from heterophilic antibodies. Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. The instrument is performing according to specifications. No further evaluation of this instrument is required.
Patient Sequence No: 1, Text Type: N, H10


[105399641] A discordant, falsely elevated total prostate specific antigen (tpsa) result was obtained on a patient sample on the dimension vista 500 system. This result was reported to the physician. The result was questioned at a later date when a new sample was tested by an alternate non-siemens methodology and a lower result was obtained. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tpsa result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2517506-2018-00221
MDR Report Key7423304
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-04-11
Date of Report2018-04-11
Date of Event2017-11-01
Date Mfgr Received2018-03-20
Date Added to Maude2018-04-11
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 ContactJAMES MORGERA
Manufacturer Street500 GBC DRIVE PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal197146101
Manufacturer Phone3026318356
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Street500 GBC DRIVE PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal Code197146101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIMENSION VISTA?
Generic NameDIMENSION VISTA? TPSA TOTAL PROSTATE SPECIFIC ANTIGEN FLEX? REAGENT CARTRIDGE
Product CodeMTF
Date Received2018-04-11
Catalog NumberK6451 SMN 10445090
Lot NumberNOT PROVIDED
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101


Patients

Patient NumberTreatmentOutcomeDate
10 2018-04-11

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