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

Model Number	3P36-35
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo F91VY 44; EI F91VY44
• MDR Report Key: 10497423
• Report Number: 3008344661-2020-00067
• Device Sequence Number: 2147371
• Product Code: LOK
• UDI-Device Identifier: 00380740112400
• UDI-Public: 00380740112400
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 09/08/2020; 11/06/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 09/15/2020; 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, (B)(6) ; ARCHITECT I2000SR,; ARCHITECT I2000SR,; LIST 03M74-02, SN (B)(6) ; LIST 03M74-02, SN (B)(6)