AXSYM RUBELLA LGG ANTIBODY 3B23-20

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 2009-03-12 for AXSYM RUBELLA LGG ANTIBODY 3B23-20 manufactured by Abbott Laboratories.

Event Text Entries

[1079550] The customer contacted abbott regarding master calibration error code 1061 (master calibration failure, incomplete calibrator results) for the axsym rubella lgg assay. The customer reported that another failed calibration occurred in 2008 with calibration deviation too large between two points. The customer was advised to replace and calibrate the sample probe and attempt recalibration. The customer reported recalibration failed and error code 1048 (calibration check failure, cal a/b, ratio too large) was generated. The customer was advised to centrifuge the calibrators and recalibrate. Recallibration of the rubella lgg assay was successful after calibrator centrifugation and quality controls were in range. There was no impact to patient management reported by the customer.
Patient Sequence No: 1, Text Type: D, B5


[8253869] 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 Number1415939-2008-00292
MDR Report Key1341438
Report Source01
Date Received2009-03-12
Date of Report2008-02-04
Date of Event2008-02-01
Date Mfgr Received2008-06-02
Date Added to Maude2009-03-12
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 FDA0
Event Location0
Manufacturer ContactKHAUDEJA BANO
Manufacturer Street100 ABBOTT PARK ROAD
Manufacturer CityABBOTT PARK IL 600646112
Manufacturer CountryUS
Manufacturer Postal600646112
Manufacturer Phone8479386319
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction Number1415939-6/06/08-004-C
Event Type3
Type of Report3

Device Details

Brand NameAXSYM RUBELLA LGG ANTIBODY
Generic NameMEIA FOR THE MEASUREMENT OF LGG ANTIBODY TO THE RUBELLA VIRUS
Product CodeGOL
Date Received2009-03-12
Model NumberNA
Catalog Number3B23-20
Lot Number56323M101
ID NumberUNK
Device Expiration Date2008-06-30
OperatorOTHER
Device AvailabilityY
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 2009-03-12

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