DIMENSION VISTA? SYSTEM K7024

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for DIMENSION VISTA? SYSTEM K7024 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[25489331] Siemens healthcare diagnostics has confirmed an increase in the rate of "abnormal assay" errors and calibration failures with the dimension vista(r) b2mic flex(r) reagent cartridge lot 15037ma. 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 healthcare diagnostics issued an urgent medical device recall communication, 15-51, dated july 2015 instructing customers to discontinue use of b2mic lot 15037ma as a result of the issue. Customers were instructed to discard any remaining inventory of the lot and to contact siemens healthcare diagnostics for replacement product.
Patient Sequence No: 1, Text Type: N, H10


[25489332] The customer reported an inability to calibrate the beta-2 microglobulin (b2mic) flex (r) reagent cartridge on the dimension vista instrument. Abnormal assay errors were obtained during the calibration process preventing acceptance of the calibration. Patient treatment was not altered or prescribed on the basis of the inability to calibrate the b2mic reagent. There is no indication of adverse patient impact due to the inability to calibrate the b2mic reagent.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610806-2015-00028
MDR Report Key4998436
Date Received2015-08-12
Date of Report2015-07-14
Date of Event2015-06-14
Date Mfgr Received2015-07-14
Device Manufacturer Date2015-02-06
Date Added to Maude2015-08-12
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 Number2517506-07232015-005-C
Event Type3
Type of Report0

Device Details

Brand NameDIMENSION VISTA? SYSTEM
Generic NameB2MIC FLEX? REAGENT CARTRIDGE AND URINE STABILIZER
Product CodeJZG
Date Received2015-08-12
Catalog NumberK7024
Device Expiration Date2016-07-14
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 2015-08-12

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