MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AFP; ALPHA-FETOPROTEIN

Catalog Number 07P90-21

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.This event is being filed on an international product (list 7p90), that has a similar us product, list 3p36.This event is also being filed under a second suspect medical device (list 8p32), under manufacturer report number 3002809144-2019-00271.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false elevated ca 19-9 xr result of 340 u/ml when processing on the alinity i.Retest results were 3.0 and 3.0 u/ml.The customer also reported false elevated afp initial result of 74.8 ng/ml, when processing on the alinity i.Retest results for afp were 11.6 and 11.1 ng/ml.No impact to patient management was reported.

Manufacturer Narrative

The catalog number in (suspect medical device) the was updated from 07p90-21 to 07p90-20.A product evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Additional information was received on 30jul2019 regarding this event that the architect afp was used off-label and not for the intended use of the assay.Based upon this new information, this complaint is no longer a reportable event.There will be no further information reported for this manufacturer report number.

• 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 Key: 8587130
• MDR Text Key: 148178914
• Report Number: 3008344661-2019-00066
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07P90-21
• Device Lot Number: 93137FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 05/13/2019; 07/30/2019
• Supplement Dates FDA Received: 06/11/2019; 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE, LIST 03R65-01; ALINITY I PROCESSING MODULE, LIST 03R65-01; SERIAL (B)(4); SERIAL (B)(4)