IMX SIROLIMUS REAGENT 5C91-21

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2006-12-18 for IMX SIROLIMUS REAGENT 5C91-21 manufactured by Abbott Laboratories.

Event Text Entries

[541083] The account stated a pt generated an imx sirolimus result of 11. 1 ng/ml. The sample was retested on a calibration run with results of 10. 0 and 10. 8 ng/ml. When the sample was tested at another laboratory using imx sirolimus, a result of 7 ng/ml was obtained. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5


[7986407] The product issue was an observed shift by a customer in imx sirolimus patient results between freshly drawn and stored (2-8 degrees c) whole blood samples after 24 hours. The investigation identified the cause as the propertieis of sirolimus in stored whole blood observed in development were not fully understood at the time; therefore, info regarding the analyte properties that were identified recently were not included in product labeling for specimen collection and storage. The studies determined that sample values may shift after storage at 2-8 degrees c or with freeze/thaw of specimens; however, the observed difference is generally not clinically significant. The investigation concluded that product performance has not changed since development of the assay, and that there is no impact on product functionality or product performance as a result of this issue. The reagent assay system is performing as intended. The sirolimus package insert is being updated to provide new info regarding sample storage and handling. Abbbot has noy rec'd any reports of adverse events related to the affected lots of imx sirolimus reagent. This is a final report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1415939-2006-00073
MDR Report Key798214
Report Source01,05,06
Date Received2006-12-18
Date of Report2006-12-14
Date of Event2006-06-27
Date Mfgr Received2006-12-14
Date Added to Maude2006-12-27
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 Location0
Manufacturer ContactDR DAVID BARCH, D-09Y6, AP6C-2
Manufacturer Street100 ABBOTT PARK ROAD
Manufacturer CityABBOTT PARK, IL 600646092
Manufacturer CountryUS
Manufacturer Postal600646092
Manufacturer Phone8479379328
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction Number1415939-12/18/06-005-C
Event Type3
Type of Report3

Device Details

Brand NameIMX SIROLIMUS REAGENT
Generic NameMEIA FOR THE QUANTITATIVE DETERMINATION OF SIROLIMUS
Product CodeJJI
Date Received2006-12-18
Model NumberNA
Catalog Number5C91-21
Lot Number063650
ID NumberNA
Device Expiration Date2006-11-08
OperatorUNKNOWN
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key785747
ManufacturerABBOTT LABORATORIES
Manufacturer Address100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US
Baseline Brand NameO,X SORP;O,IS REAGEMT
Baseline Generic NameMEIA FOR THE QUANTITATIVE DETERMINATION OF SIROLIMUS
Baseline Model NoNA
Baseline Catalog No5C91-21
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2006-12-18

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