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

Catalog Number 03P36-26

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a falsely elevated architect afp result.Sample id (b)(6)generated an initial result of 595.27 ng/ml and retest of the sample on a second architect instrument generated 3.68 ng/ml.No specific patient information was provided.No adverse impact to patient management was reported.

Manufacturer Narrative

Further investigation of the issue included a review of the complaint text, a search for similar complaints, in-house testing and a review of labeling.Additional information provided in the complaint text indicated the customer confirmed that the false elevated result was due to an incident with the specimen i.E.Fibrin had adhered to the probe and caused issues at the wash zone leading to elevated rlu values.Review of complaint activity determined that there is normal complaint activity for likely cause lot 70095fn00.Tracking and trending report review for the architect afp assay determined that there are no related adverse or non-statistical trends.Using world wide field data the historical performance of reagent lot 70095fn00 was evaluated and compared to the performance of all architect afp reagent lots in the field.This evaluation indicated that the patient median result for lot 70095fn00 was similar to the other architect afp reagent lots.Therefore, no unusual reagent lot performance was identified for lot 70095fn00.Testing of a serum based panel sample with a target to a known concentration, was performed using an in-house retained kit of lot 70095fn00.All specifications were met indicating that lot 70095fn00 is performing acceptably.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect afp assay was identified.Correction: lot number was initially reported in serial number field.The lot number has been entered in the correct field.

• 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: 6684235
• MDR Text Key: 78984859
• Report Number: 3008344661-2017-00060
• 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
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2017
• Device Catalogue Number: 03P36-26
• Device Lot Number: 70095FN00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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; LIST 03M74-01, SERIAL (B)(4)