DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM K7052

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-01 for DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM K7052 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[2778101] A series of falsely depressed immunoglobulin a (iga) results was reported on a patient's samples. The results were reported to the physician. The patient was tested by an alternate methodology (electrophoresis) and elevated results were obtained. The original samples were retested and elevated results were confirmed. It is unknown if patient treatment was altered or prescribed. There is no report of adverse outcome to the patient as a result of initial falsely depressed iga results.
Patient Sequence No: 1, Text Type: D, B5


[10113269] Analysis of the instrument and instrument data indicate that the cause for the falsely depressed iga results is unknown. The dimension vista(r) iga flex(r) reagent cartridge ifu in the limitations of "procedure section states: "the iga method has been designed to minimize antigen excess in the initial sample dilution. However, it cqnnot be completeley eliminated and in rare cases very high immunoglobulin concentrations may produce falsely-low results. Monoclonal immunoglobulins may show reactivity different from the polyclonal calibrator, which in isolated cases may lead to artificially decreased or non-linear results. " the instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610806-2012-00008
MDR Report Key2677875
Report Source05,06
Date Received2012-08-01
Date of Report2012-07-03
Date of Event2012-06-20
Date Mfgr Received2012-07-03
Device Manufacturer Date2011-07-14
Date Added to Maude2012-11-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJAMES MORGERA
Manufacturer StreetGLASGOW BUSINESS COMMUNITY PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal197146101
Manufacturer Phone3026318356
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer Street76 EMIL VON BEHRING STRASSE
Manufacturer CityMARBURG, 35041
Manufacturer CountryGM
Manufacturer Postal Code35041
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM
Generic NameIMMUNOGLOBULIN A FLEX? REAGENT CARTRIDGE
Product CodeCFQ
Date Received2012-08-01
Catalog NumberK7052
Lot Number11195MA
Device Expiration Date2012-12-29
OperatorMEDICAL TECHNOLOGIST
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer Address76 EMIL VON BEHRING STRASSE MARBURG, 35041 GM 35041


Patients

Patient NumberTreatmentOutcomeDate
10 2012-08-01

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