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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AFP; ALPHA-FETOPROTEIN
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ABBOTT IRELAND ARCHITECT AFP; ALPHA-FETOPROTEIN Back to Search Results
Catalog Number 03P36-30
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
 
Event Description
The customer observed a falsely elevated alpha 1 fetoprotein (afp) results on the architect i2000sr analyzer.The following data was provided: initial 53.14 ng/ml, repeat 4.6 ng/ml.There was no impact to patient management reported.
 
Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and accuracy testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The product was not available for return.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
 
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Brand Name
ARCHITECT AFP
Type of Device
ALPHA-FETOPROTEIN
Manufacturer (Section D)
ABBOTT IRELAND
diagnostics division
finisklin business park
sligo NA
EI  NA
MDR Report Key7865546
MDR Text Key120560641
Report Number3008344661-2018-00074
Device Sequence Number1
Product Code LOK
Combination Product (y/n)N
PMA/PMN Number
P120008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 11/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/09/2019
Device Catalogue Number03P36-30
Device Lot Number85019FN00
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02 ,SN (B)(4); LN 03M74-02, SN (B)(4)
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