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

Catalog Number 03P36-25

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

Complete patient identification: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false elevated afp initial result when processing on the architect i2000sr.The initial result was 581.87 and retest was 3.28 ng/ml.A new blood draw generated a result of 3.2 ng/ml.A previous afp result from 3 months prior was 3 ng/ml.Additional diagnostic testing was provided for this patient: (b)(6).Alt was 70 and ast was 40.No impact to patient management was reported.

Event Description

Addtional information from the customer stated that on admission the patient underwent an mri examination and the patient was discharged without any particular medication or treatment.

Manufacturer Narrative

Event was updated to include additional information received from the customer regarding the event.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, testing of a retained kit of lot 91429fn00, a search for similar complaints, a review of trending data, a review of the historical performance for reagent lot 91429fn00, a review of product quality history, and a review of product labeling.Testing was performed using an in-house retained kit of lot 91429fn00 and all specifications were met indicating the lot is preforming acceptably.The ticket searches determined normal complaint activity for the likely cause lot.Complaint trending report review determined that there is no non-statistical or adverse trend for the product for the complaint issue.World wide data was used to review the historical performance of lot 91429fn00 and determined the patient median result for the lot is comparable with all other lots in the field and confirms no systemic issue for the lot.A review of the product quality history for the lot did not identify issues associated with the customer observation.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• Brand Name: ARCHITECT AFP
• Type of Device: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8599438
• MDR Text Key: 190815897
• Report Number: 3008344661-2019-00067
• Device Sequence Number: 1
• Product Code: LOK
• UDI-Device Identifier: 00380740081317
• UDI-Public: 00380740081317
• Combination Product (y/n): N
• PMA/PMN Number: P120008
• 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: 07/29/2019

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: 08/29/2019
• Device Catalogue Number: 03P36-25
• Device Lot Number: 91429FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/05/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 05/13/2019; 07/23/2019
• Supplement Dates FDA Received: 06/11/2019; 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR, LIST 03M74-02; SERIAL (B)(4)
• Patient Age: 41 YR