MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TOTAL PSA REAGENT KIT; TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER

Catalog Number 07P92-20

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity i total psa results for one sample.The following data was provided: two primary sample tubes were drawn off-site, the customer prepared an aliquot of each tube.(b)(6) 2024 aliquot 1 result = 6.84 ug/l, repeat = 4.06 ug/l; free psa result = 0.296 ug/l a new sample was collected: (b)(6) 2024 = results were within normal range the customer reran the original primary tube and the aliquot 2 tube.Primary tube result = 0.80 ug/l, aliquot 2 result = 0.80 ug/l no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 8p32-20 has a similar product distributed in the us, list number 8p32-21/-31.

Manufacturer Narrative

The complaint investigation for falsely depressed alinity i total psa results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A search for similar complaints for lot 53645fn00 did not identify an increase in complaint activity.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 53645fn00 and the complaint issue.Labeling was reviewed and found to be adequate.In this case testing of sample 2 aliquot drawn from the patient on the same day and of the primary tube for sample 1, both generated the expected results.The same sample 1 aliquot also generated an aberrant creatinine result.Based on the investigation alinity i total psa reagent lot 53645fn00 is performing as intended, no systemic issue or deficiency of the alinity i total psa reagent was identified.

Event Description

The customer observed falsely elevated alinity i total psa results for one sample.The following data was provided: two primary sample tubes were drawn off-site, the customer prepared an aliquot of each tube.05jan2024 aliquot 1 result = 6.84 ug/l, repeat = 4.06 ug/l; free psa result = 0.296 ug/l a new sample was collected: 11jan2024 = results were within normal range the customer reran the original primary tube and the aliquot 2 tube.Primary tube result = 0.80 ug/l, aliquot 2 result = 0.80 ug/l no impact to patient management was reported.

• Brand Name: ALINITY I TOTAL PSA REAGENT KIT
• Type of Device: TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18550825
• MDR Text Key: 333343473
• Report Number: 3008344661-2024-00011
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07P92-20
• Device Lot Number: 53645FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)