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

Model Number	3P36-25
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated alpha-fetoprotein (afp) results while using the architect afp reagents.The following data was provided.Initial 63.1 ng/ml, repeat 42.9 ng/ml.A new specimen was obtained and the result was lower, 2.2 ng/ml.Result for this specimen in another laboratory was 1.9 ng/ml.The patient is a child that was diagnosed with immature teratoma of the retroperitoneal space and was treated in 2015.The patient was being monitored after treatment of germogenic tumors.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from architect afp reagent to architect i1000sr analyzer.Mdr number 1628664-2017-00353 has been submitted for this issue and all further information will be documented under that mdr number.An evaluation is in process.

• Brand Name: ARCHITECT AFP
• Common Device Name: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 6856406
• Report Number: 3008344661-2017-00080
• Device Sequence Number: 683359
• Product Code: LOK
• UDI-Device Identifier: 00380740081317
• UDI-Public: (01)00380740081317(17)171102(10)70095FN00
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P120008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3P36-25
• Device Catalogue Number: 03P36-25
• Device Lot Number: 70095FN00
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 MO