DIMENSION VISTA? K6435 SMN10488927

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-12-11 for DIMENSION VISTA? K6435 SMN10488927 manufactured by Siemens Healthcare Diagnostics Inc.

Event Text Entries

[94499700] Mdr 2517506-2017-00861, mdr 2517506-2017-00862, mdr 2517506-2017-00863, mdr 2517506-2017-00864, mdr 2517506-2017-00865, mdr 2517506-2017-00866, mdr 2517506-2017-00867, mdr 2517506-2017-00868, mdr 2517506- 2017-00869, mdr 2517506-2017-00870, mdr 2517506-2017-00872, mdr 2517506-2017-00873, mdr 2517506-2017-00874, mdr 2517506-2017-00875 were also filed for the same customer inquiry. The customer contacted siemens customer care center for the discordant elevated digoxin result on the dimension vista instrument. Quality control was within specification during testing. Siemens is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10


[94499701] A discordant falsely elevated digoxin (digxn) result was obtained on a patient sample on the dimension vista 1500 instrument. The result was reported to the physician who questioned the result. The same sample was tested twice earlier on an alternate vista instrument and high results were obtained. The same sample was repeated three times later on the same vista instrument and high results were obtained. A 1:3 and 1:2 manual dilution was performed on the last two repeats and high results were obtained on the same sample. The clinician started to question the result since it had increased when no digoxin was given to the patient. There is no known report of patient adverse health consequences due to the discordant falsely elevated digxn result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2517506-2017-00871
MDR Report Key7103746
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-12-11
Date of Report2018-01-19
Date of Event2017-11-10
Date Mfgr Received2018-01-04
Device Manufacturer Date2017-04-14
Date Added to Maude2017-12-11
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? DIGXN LOCI DIGOXIN FLEX? REAGENT CARTRIDGE
Product CodeKXT
Date Received2017-12-11
Catalog NumberK6435 SMN10488927
Lot Number17103BC
Device Expiration Date2018-04-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2017-12-11

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