CLINICAL CHEMISTRY IRON 7D68-30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2008-09-17 for CLINICAL CHEMISTRY IRON 7D68-30 manufactured by Abbott Manufacturing, Inc..

Event Text Entries

[924821] The account stated that the results from the architect iron assay are non-reproducible. For patient #1, the initial result = 12 ug/dl, the sample was then tested in duplicate and both results were 43 ug/dl. The account states the initial result which is too low is the incorrect result. There was no impact to pt management reported.
Patient Sequence No: 1, Text Type: D, B5


[8098474] (b) (4). 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


[16497805] (b)(4). The customer was complaining of iron reproducibility issues. Maintenance was up to date. Customer using clinical chemistry iron, ln 7d68-30, exp 10/30/2008 and iron/mg calibrator, ln 1e69-03, exp 6/9/2008. It was later identified the customer was using expired calibrators when the suspect results were generated. Review the clinical chemistry iron/ magnesium calibrator package insert commodity #(b)(4)was performed. Page 1, "warnings and precautions" section states; "do not use components beyond the expiration date". Review of the abbott metric reports indicated no similar complaints were found. This is the final report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2018433-2008-00184
MDR Report Key1171504
Report Source00,01
Date Received2008-09-17
Date of Report2008-09-03
Date of Event2008-09-01
Date Mfgr Received2009-03-09
Device Manufacturer Date2007-12-09
Date Added to Maude2010-03-03
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 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 MANUFACTURING, INC.
Manufacturer Street820 MISSION ST.
Manufacturer CitySOUTH PASADENA CA 91030350
Manufacturer CountryUS
Manufacturer Postal Code91030 3500
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLINICAL CHEMISTRY IRON
Generic NameFOR THE QUANTITATION OF IRON IN HUMAN SERUM
Product CodeCFM
Date Received2008-09-17
Model NumberNA
Catalog Number7D68-30
Lot Number60030HW00
ID NumberNA
Device Expiration Date2007-06-09
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MANUFACTURING, INC.
Manufacturer Address820 MISSION ST. SOUTH PASADENA CA 91030350 US 91030 3500


Patients

Patient NumberTreatmentOutcomeDate
10 2008-09-17

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