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

Catalog Number 03P36-26

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information; patient identifier - the complete first sid is (b)(6) and the follow-up sid is (b)(6).

Event Description

The customer stated that the architect analyzer generated falsely elevated afp results on one patient.The results provided were: (b)(6) on (b)(6) 2016 = 346ng/ml / afp l3 fraction from outsource = 2.6.The customer repeated a sample ((b)(6) on (b)(6) 2016) from the same patient /same day, different tube, and obtained 4.7.There was no reported impact to patient management.There was no additional patient information provided.

Manufacturer Narrative

On 02dec2016 customer support provided the lot number- lot # from unknown to 62214fn00.The customer observed a single false elevated afp result using architect afp, list 3p36-25 ((b)(4) list number 3p36-26), lot 62214fn00.No patient sample was available to assist in the investigation.A review of complaints found no trend for lot 62214fn00.Accuracy testing was performed with a file sample of lot 62214fn00 and a serum based panel sample with a target concentration of 20 ng/ml.All specifications were met indicating that lot 62214fn00 is performing acceptably.A review of the manufacturing records for this lot did not identify any issues associated with the customer observation.A review of labeling shows adequate information is provided to address discrepant results including sample integrity / sample handling issues.The architect system operations manual provides troubleshooting for falsely elevated results.Based on all available information and this investigation, the assay performed as intended and no product deficiency was identified.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended.

• Brand Name: ARCHITECT AFP
• Type of Device: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer (Section G): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6112860
• MDR Text Key: 60377723
• Report Number: 3008344661-2016-00072
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2017

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 Expiration Date: 03/11/2017
• Device Catalogue Number: 03P36-26
• Device Lot Number: 62214FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/21/2016; 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,; SERIAL # (B)(4)