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

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer observed (b)(6) alpha 1 fetoprotein (afp) results on the architect i2000sr analyzer.The following data was provided for a (b)(6) year old female patient: initial (b)(6), repeat (b)(6), (b)(6) ng/ml.The results were compared to another method (b)(6) ng/ml, which matches the clinical presentation of the patient.There was no impact to patient management reported.

Manufacturer Narrative

The likely cause size code was updated on march 22, 2019 from 03p36-26 to 03p36-25.An investigation is still in process.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling, as the product was used off-label.No adverse trend was identified for the customer's issue.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within expected limits.The labeling review found to adequately indicate this product is clearly labeled an aid in monitoring disease progression during the course of disease and treatment of patients with nonseminomatous testicular cancer and also to aid in the detection of fetal open neural tube defects.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was 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: 8426345
• MDR Text Key: 142624112
• Report Number: 3008344661-2019-00029
• Device Sequence Number: 1
• Product Code: LOK
• 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: 07/30/2019

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: 04/17/2019
• Device Catalogue Number: 03P36-25
• Device Lot Number: 88061FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/10/2019
• Initial Date FDA Received: 03/16/2019
• Supplement Dates Manufacturer Received: 03/22/2019; 07/29/2019
• Supplement Dates FDA Received: 03/22/2019; 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-01 SN (B)(4) ; LN 03M74-01 SN (B)(4) ; LN 03M74-01 SN(B)(4)
• Patient Age: 63 YR