ARCHITECT SIROLIMUS 1L76-25

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-22 for ARCHITECT SIROLIMUS 1L76-25 manufactured by Abbott Laboratories.

Event Text Entries

[1634802] The customer observed architect sirolimus reagent barcode read errors when reagent lot 80126m00 was in use. The customer stated that the barcode read errors were observed only with the sirolimus reagent and was able to run the assay after cleaning the barcode reader. The customer was sent a replacement new lot of reagent which resolved the issue. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5


[8618843] (b)(4), concomitant medical device: architect i2000sr analyzer, list # 3m74-01 (b)(4). The cause of the architect sirolimus reagent barcode read error was poor print quality from a single barcode printer. A product recall was issued on (b)(4) 2010 for architect sirolimus reagent lot 80162m100 and abbott customers were notified to discontinue and/or destroy any remaining inventory of this lot. No other lots of architect sirolimus reagent were affected. 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


[8782184] (b)(4). Concomitant medical products: architect i2000sr analyzer, list # 3m74-01, (b)(4). The cause of the architect sirolimus barcode read error was poor print quality from a single barcode printer. A product recall was issued on (b)(4) 2010 for architect sirolimus reagent lot 80162m100 and abbott customers were notified to discontinue and/or destroy any remaining inventory of this lot. No other architect sirolimus reagent lots were affected.
Patient Sequence No: 1, Text Type: N, H10


[17059236] (b)(4). Architect i2000sr analyzer, list #3m74-01, (b)(4). The cause of the architect sirolimus barcode read error was poor print quality from a single barcode printer. A product recall was issued on 5/27/10 for architect sirolimus reagent lot 80162m100 and abbott customers were notified to discontinue and/or destroy any remaining inventory of this lot. No other architect sirolimus reagent lots were affected.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1415939-2010-00362
MDR Report Key1731420
Report Source05
Date Received2010-06-22
Date of Report2010-04-29
Date Mfgr Received2010-11-24
Device Manufacturer Date2009-11-09
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 Number1415939-5/28/10-002-R
Event Type3
Type of Report3

Device Details

Brand NameARCHITECT SIROLIMUS
Generic NameCMIA FOR THE QUANTITATIVE DETERMINATION OF SIROLIMUS IN HUMAN BLOOD
Product CodeNRP
Date Received2010-06-22
Catalog Number1L76-25
Lot Number80162M100
Device Expiration Date2011-05-03
OperatorHEALTH PROFESSIONAL
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 2010-06-22

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