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

[20942092] The customer reported three failed axsym rubella lgg calibrators, where error code 1048 (calibration check failure, calibrators a/b ratio too high) was generated. Another failed attempted calibration was performed with a different calibrator lot where error code 1111 (calibration check failure, master calibrator 1, result too high) was generated. The customer was sent another lot of reagent and abbott requested faxes of the calibration data for evaluation. The customer reported the axsym probes were recently replaced. Upon follow up with the customer after new lot of rubella reagent was sent, the customer reported everything had returned to normal. Additionally the customer reported there was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5


[21201731] 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 Number1415939-2008-00277
MDR Report Key1341463
Report Source01
Date Received2009-03-12
Date of Report2007-12-06
Date of Event2007-12-05
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 Number53587M101
ID NumberNA
Device Expiration Date2008-04-15
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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