ARCHITECT FSH CALIBRATOR 6C24-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2006-12-01 for ARCHITECT FSH CALIBRATOR 6C24-01 manufactured by Abbott Diagnostics International, Ltd..

Event Text Entries

[581307] The customer states that they noticed a shift up in controls (biorad) and pt results when using the architect fsr assay with architect fsh calibrators lot number 33363q1. Pt results were reported out of the lab with qc out of range. No impact to pt mgmt was reported.
Patient Sequence No: 1, Text Type: D, B5


[7941951] Following a customer complaint, abbott found an atypical stability profile of architect fsh calibrator lot 33363q100. The investigation to date has shown that both controls and pt results have shifted upwards together over time. There has been no adverse events associated with this issue to date. This is an intial 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 Number2623532-2006-00025
MDR Report Key793635
Report Source01,05,06
Date Received2006-12-01
Date of Report2006-08-31
Date of Event2006-07-24
Date Mfgr Received2006-08-31
Device Manufacturer Date2005-09-01
Date Added to Maude2006-12-14
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 FDA3
Event Location0
Manufacturer ContactDR. DAVID BARCH, D-D09Y6, AP6C-2
Manufacturer Street100 ABBOTT PARK RD
Manufacturer CityABBOTT PARK IL 600646092
Manufacturer CountryUS
Manufacturer Postal600646092
Manufacturer Phone8479379328
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ-0024-2007
Event Type3
Type of Report3

Device Details

Brand NameARCHITECT FSH CALIBRATOR
Generic NameCMIA FOR THE QUANTITATIVE DETERMINATION OF FSH IN HUMAN SERU
Product CodeCGJ
Date Received2006-12-01
Model NumberNA
Catalog Number6C24-01
Lot Number33363Q100
ID NumberNA
Device Expiration Date2006-11-04
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key781252
ManufacturerABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
Manufacturer AddressKM 58.0 CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 US
Baseline Brand NameARCHITECT FSH CALIBRATOR
Baseline Generic NameCMIA FOR QUANTITATIVE DETERMINATION OF FSH IN HUMAN SERUM AN
Baseline Model NoNA
Baseline Catalog No6C24-01
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2006-12-01

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