IMX SIROLIMUS 5C91-83

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2010-06-04 for IMX SIROLIMUS 5C91-83 manufactured by Abbott Laboratories.

Event Text Entries

[8909409] (b)(4). Suspect medical device, expiration date: the correct expiration date of imx sirolimus reagent lot 802873106 is 5/13/10, not 7/23/10 as was submitted in the initial medwatch submission. The imx sirolimus calibration errors generated with reagent lot 802873106 were caused by a calibration curve ratio outside the imx sirolimus assay file limits for the imx sirolimus calibrator b/calibrator a and calibrator f/calibrator a. A product recall was issued and a letter was sent to abbott customers with instructions to discontinue use and destroy the suspect imx sirolimus reagent and switch to a replacement lot of reagent.
Patient Sequence No: 1, Text Type: N, H10


[16639060] The customer observed imx sirolimus calibration failure code 161 (check 5 out of range) when reagent lot 802873106 was in use. The customer performed a passing photo check, however, the analyzer dispense check failed, therefore, the customer was advised to change the diluent syringe and perform a probe decontamination. The customer achieved a successful recalibration on a different analyzer in the lab. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5


[16663566] (b)(4). This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1415939-2010-00349
MDR Report Key1710928
Report Source01
Date Received2010-06-04
Date of Report2010-04-23
Date of Event2010-04-23
Date Mfgr Received2010-11-24
Device Manufacturer Date2009-09-01
Date Added to Maude2010-12-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactNOEMI KONDOS RN, BSN
Manufacturer Street200 ABBOTT PARK ROAD DEPT. 09B9, AP50
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone8479375120
Manufacturer G1ABBOTT LABORATORIES
Manufacturer Street100 ABBOTT PARK ROAD
Manufacturer CityABBOTT PARK IL 60064350
Manufacturer CountryUS
Manufacturer Postal Code60064 3500
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number1415939-5/3/10-001-R
Event Type3
Type of Report3

Device Details

Brand NameIMX SIROLIMUS
Generic NameFOR THE QUANTITATIVE DETERMINATION OF SIROLIMUS IN HUMAN WHOLE BLOOD
Product CodeNRP
Date Received2010-06-04
Catalog Number5C91-83
Lot Number802873106
Device Expiration Date2010-05-13
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT LABORATORIES
Manufacturer Address100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500


Patients

Patient NumberTreatmentOutcomeDate
10 2010-06-04

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