DIMENSION VISTA? SYSTEM K7024

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 2015-10-14 for DIMENSION VISTA? SYSTEM K7024 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[28248137] Siemens healthcare diagnostics is investigating an increase in the rate of "abnormal assay" errors and calibration failures with the dimension vista(r) b2mic flex(r) reagent cartridge lot 15204ma. The errors can occur on calibration, qc, and/or patient samples. As stated in the dimension vista operator's guide, results with abnormal assay flags are not reportable.
Patient Sequence No: 1, Text Type: N, H10


[28248138] The customer complained of obtaining abnormal assay e143 flags on qc with the beta-2 microglobulin (b2mic) flex (r) reagent cartridge on the dimension vista instrument. The account did not have an alternate lot available. There is no indication that patient treatment was altered or prescribed on the basis of the abnormal assay flags on b2mic results. There is no indication of adverse patient impact due to the abnormal assay flags on b2mic results.
Patient Sequence No: 1, Text Type: D, B5


[32248027] Original mdr was submitted 2015-10-14. Siemens healthcare diagnostics has confirmed complaints of an increase in the rate of "abnormal assay" errors and calibration failures with the dimension vista b2mic flex reagent cartridge lots 15175ma, 15204ma, 15246ma and 15267ma. The errors can occur on calibration, qc and/or patient samples. As stated in the dimension vista operator's guide, results with "abnormal assay" flags are not reportable. Siemens issued an urgent medical device recall communication br-00816 dated november 2015 to customers who had ordered the impacted lots advising them to discontinue the use of the lot.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610806-2015-00034
MDR Report Key5149517
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2015-10-14
Date of Report2015-11-03
Date of Event2015-08-31
Date Mfgr Received2015-09-16
Device Manufacturer Date2014-12-04
Date Added to Maude2015-10-14
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 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
Removal Correction NumberZ-2450-2015
Event Type3
Type of Report3

Device Details

Brand NameDIMENSION VISTA? SYSTEM
Generic NameB2MIC FLEX? REAGENT CARTRIDGE AND URINE STABILIZER
Product CodeJZG
Date Received2015-10-14
Catalog NumberK7024
Lot Number15204MA
Device Expiration Date2017-01-13
OperatorMEDICAL TECHNOLOGIST
Device AvailabilityN
Device AgeDA
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 2015-10-14

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