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 foreign,health professional,u report with the FDA on 2015-11-26 for DIMENSION? SIROLIMUS FLEX? REAGENT CARTRIDGE DF306 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.

Event Text Entries

[32198693] The cause of the imprecision with qc and patient samples with sirolimus lot eb6064 is unknown. The customer moved testing to an alternate lot. The issue is under investigation by siemens healthcare diagnostics.
Patient Sequence No: 1, Text Type: N, H10


[32198694] A customer reported imprecision of sirolimus (siro) results with qc and patient samples with lot eb6064. It is unknown if the initial patient results have been reported to physicians. The samples were repeated on an alternate lot of reagent and the repeat results with lot fa6136 were reported. It is not alleged that patient treatment was altered or prescribed on the basis of the imprecise siro results. There was no report of adverse health consequences as a result of the imprecise siro results.
Patient Sequence No: 1, Text Type: D, B5


[38123655] 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 the 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 dc-16-01. B. Us 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


MAUDE Entry Details

Report Number2517506-2015-00210
MDR Report Key5252470
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2015-11-26
Date of Report2016-02-02
Date of Event2015-11-01
Date Mfgr Received2015-11-04
Device Manufacturer Date2015-03-03
Date Added to Maude2015-11-26
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 FDA3
Event Location3
Manufacturer ContactEDWARD SZYMANSKI
Manufacturer StreetGLASGOW BUSINESS COMMUNITY PO BOX 6101
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
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? SIROLIMUS FLEX? REAGENT CARTRIDGE
Product CodeNRP
Date Received2015-11-26
Catalog NumberDF306
Lot NumberEB6064
Device Expiration Date2016-03-04
OperatorMEDICAL TECHNOLOGIST
Device AvailabilityN
Device AgeDA
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 2015-11-26

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