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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 Date 12/02/2019
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
 
Event Description
The customer reported a falsely increased architect afp result on a (b)(6) yr old male patient.Results provided: (b)(6) 2019 = 619.1 ng/ml; 20149 = 225.9 ng/ml.It is unknown if the patient has cancer.No impact to patient management was reported.
 
Manufacturer Narrative
A review of tickets was performed for the likely cause architect afp reagent lot number 96303fn00.The ticket search determined that there is normal complaint activity for this lot number.To evaluate the historical performance of the reagent lot, worldwide field data was reviewed.The patient median population result for the lot was comparable with all other lots in the field.Therefore, no unusual reagent lot performance was identified.A review of the manufacturing documentation did not identify any issues associated with the customers observation.Return testing was not completed as returns were not available.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect afp lot# 96303fn00 assay.
 
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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 Key9495601
MDR Text Key219573416
Report Number3008344661-2019-00150
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 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2020
Device Catalogue Number03P36-30
Device Lot Number96303FN00
Was Device Available for Evaluation? No
Date Manufacturer Received01/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT I2000SR ANALYZER LIST 03M74-98; ARCHITECT I2000SR ANALYZER LIST 03M74-98; SERIAL (B)(6) ; SERIAL (B)(6)
Patient Age55 YR
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