AXSYM PHENYTOIN 7A67-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-02-23 for AXSYM PHENYTOIN 7A67-20 manufactured by Abbott Diagnostics Int'l, Ltd.

Event Text Entries

[1318185] The customer stated that samples from one patient tested on different dates ((b)(6)) generated discrepant axsym phenytoin results. For example, an initial result of 0. 59 ug/ml was repeated at 0. 45 ug/ml, reported out of the lab and was questioned by the patient's physician as it was lower than expected. The same sample was then retested with a result of more than 40 ug/ml. Stored samples from the same patient were sent to a reference lab (axsym system) and results between 24. 32 ug/ml and more than 40 ug/ml were generated. Quality controls were all within the expected ranges and there was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5


[8444209] (b)(4). This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete. An investigation is in process.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2623532-2010-00008
MDR Report Key1611994
Report Source01,05
Date Received2010-02-23
Date of Report2010-01-27
Date of Event2010-01-26
Date Mfgr Received2010-03-17
Device Manufacturer Date2009-05-22
Date Added to Maude2011-10-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
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 DIAGNOSTICS INT'L, LTD
Manufacturer StreetKM 58.0 CARRETERA 2 CRUCE DAVILA
Manufacturer CityBARCELONETA PR 00617
Manufacturer Postal Code00617
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAXSYM PHENYTOIN
Generic NameFOR THE MEASUREMENT OF PHENYTOIN IN HUMAN SERUM OR PLASMA
Product CodeLGR
Date Received2010-02-23
Catalog Number7A67-20
Lot Number74550Q100
Device Expiration Date2010-02-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT DIAGNOSTICS INT'L, LTD
Manufacturer AddressKM 58.0 CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 00617


Patients

Patient NumberTreatmentOutcomeDate
10 2010-02-23

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