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

Model Number 3P36-35

Device Problem High Test Results (2457)

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

Event Date 08/22/2020

Event Type  malfunction  

Manufacturer Narrative

All available patient information is included.No additional information was provided.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely elevated architect alpha - fetoprotein (afp) results were generated on the architect i2000sr for a female patient during physical examination.The following results were provided: initial result 184.32 ng/ml, retest result 2.23 ng/ml [reference range = 0 - 8.78 ng/ml].There was no reported impact to patient management.

Manufacturer Narrative

Section b5.Describe event or problem was updated to include the additional information provided by customer on 08sep2020 an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.H3 other text : an evaluation is in process.

Event Description

The customer reported falsely elevated architect alpha - fetoprotein (afp) results were generated on the architect i2000sr for a female patient during physical examination.The following results were provided: initial result 184.32 ng/ml, retest result 2.23 ng/ml [reference range = 0 - 8.78 ng/ml].On 08sep2020, the customer reported falsely elevated architect alpha-fetoprotein results were generated for 2 more patients.The following results were provided: 54 year old male- initial result 282.08 ng/ml, retest result 4.10 ng/ml.49 year old male- initial results 89.81 ng/ml, retest result 4.06 ng/ml.There was no reported impact to patient management.

Manufacturer Narrative

The complaint investigation for potential false elevated afp results included a search for similar complaints, and review of complaint text, trending data, labelling, and device history records review.Return testing was not completed as returns were not available.A review of complaint activity identified there was normal complaint activity for lot 11476fn00.Tracking and trending was reviewed and determined there were no trends identified for the architect afp reagent.The performance of the architect afp reagent lot 11476fn00 was evaluated using world wide data field data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 11476fn00 is within the established control limits and no unusual reagent lot performance was seen.Manufacturing documentation was reviewed and no issues were identified.Additionally, labeling was reviewed and adequately addresses the customer issue.Based on the investigation, no systemic issue or product deficiency of the architect afp reagent, lot number 11476fn00 was identified.

• Brand Name: ARCHITECT AFP
• Type of Device: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo F91VY 44; EI F91VY44
• MDR Report Key: 10497423
• MDR Text Key: 221565664
• Report Number: 3008344661-2020-00067
• Device Sequence Number: 1
• Product Code: LOK
• UDI-Device Identifier: 00380740112400
• UDI-Public: 00380740112400
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: 3P36-35
• Device Catalogue Number: 03P36-74
• Device Lot Number: 11476FN00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6) ; ARCHITECT I2000SR,; ARCHITECT I2000SR,; LIST 03M74-02, SN (B)(6) ; LIST 03M74-02, SN (B)(6)