DIMENSION? SIROLIMUS FLEX? REAGENT CARTRIDGE DF306

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 2016-02-09 for DIMENSION? SIROLIMUS FLEX? REAGENT CARTRIDGE DF306 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.

Event Text Entries

[37795281] Siemens healthcare diagnostics received customer complaints for dimension sirolimus (siro) lot eb6064. The complaints were related to qc shifts and imprecision. Siemens healthcare diagnostics conducted an investigation on board stability for dimension siro lot eb6064. Investigation determined that dimension siro lot eb6064 does not meet the open well stability claim of two days. Internal testing has shown biases ranging from -82% to +123% on a pooled sample with a sirolimus concentration o 8. 7 ng/ml [9. 5 mmol/l] when tested on subsequent days of the two day open well stability period. Results are unaffected at the start of the open well stability period. Quality control is likely to catch the issue on subsequent days of the open well stability claim. Siemens healthcare diagnostics issued an urgent medical device recall communication (b)(4) dated february, 2016 instructing customers to discontinue use and discard any remaining inventory of the affected lot and to contact siemens healthcare for replacement product.
Patient Sequence No: 1, Text Type: N, H10


[37795282] A customer complained about qc having high assay range flags and precision issues with sirolimus (siro) lot eb6064. It is unknown if patient treatment was altered or prescribed on the basis of the poor precision with siro lot eb6064. There was no report of adverse health consequences as a result of poor precision with siro lot eb6064.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2517506-2016-00014
MDR Report Key5419947
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2016-02-09
Date of Report2016-02-02
Date of Event2015-07-16
Date Mfgr Received2016-02-02
Device Manufacturer Date2015-03-03
Date Added to Maude2016-02-09
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 ContactEDWARD SZYMANSKI
Manufacturer StreetGLASGOW BUSINESS COMMUNITY PO BOX 6101 M/S 514
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal197146101
Manufacturer Phone3026317672
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
Manufacturer StreetGLASGOW BUSINESS COMMUNITY 500 GBC DRIVE
Manufacturer CityNEWARK DE 19714
Manufacturer CountryUS
Manufacturer Postal Code19714
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number2517506-02/12/2016-001-C
Event Type3
Type of Report3

Device Details

Brand NameDIMENSION? SIROLIMUS FLEX? REAGENT CARTRIDGE
Generic NameDIMENSION? SIRO
Product CodeNRP
Date Received2016-02-09
Catalog NumberDF306
Lot NumberEB6064
Device Expiration Date2016-03-04
OperatorMEDICAL TECHNOLOGIST
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
Manufacturer AddressGLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19714 US 19714


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-09

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