ARCHITECT LH 6C25-27

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 2007-07-26 for ARCHITECT LH 6C25-27 manufactured by Abbott Laboratories.

Event Text Entries

[15033308] The customer stated that while running the architect i2000sr, error code #1227 (assay (lh)number(641) calibration failure, fit concentration too high for cal f) generated before and after calibration using the lh assay reagent. There was no impact to pt management reported.
Patient Sequence No: 1, Text Type: D, B5


[15305823] An investigation is in process. A final report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1415939-2007-00202
MDR Report Key885309
Report Source01,05
Date Received2007-07-26
Date of Report2007-02-06
Date of Event2007-02-06
Date Mfgr Received2007-02-06
Date Added to Maude2007-08-21
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 ContactDR. DAVID BARCH, D-09YG, APGC-2
Manufacturer Street100 ABBOTT PARK RD.
Manufacturer CityABBOTT PARK IL 600646092
Manufacturer CountryUS
Manufacturer Postal600646092
Manufacturer Phone8479379328
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number1415939-11/29/06-004-C
Event Type3
Type of Report3

Device Details

Brand NameARCHITECT LH
Generic NameCMIA FOR THE QUANTITATIVE DETERMINATION OF HUMAN LUTEINIZING HORMONE
Product CodeCEP
Date Received2007-07-26
Model NumberNA
Catalog Number6C25-27
Lot Number33198M201
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key864866
ManufacturerABBOTT LABORATORIES
Manufacturer Address100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-07-26

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