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	07P92-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer stated that error 1044, unable to calculate result.Final rlu read is outside the specification of the lowest calibrator for total psa, was generated for three patient samples while using the alinity i total psa assay.Two of the three samples were tested on a different alinity i processing module and the same error occurred.The customer stated that two of the patients did have very low total psa results historically.The customer used new total psa calibrator lot 51060fn00 to resolve the issue and the three patient samples were retested.Patient 1 and 2: alinity i total psa result: <0.1 ng/ml.The results were expected to be low for both patients.No historical values were provided.Patient 3: alinity i total psa result: <0.1 ng/ml.Alinity i total psa result (different sample tube): 3.86 and 4.12 ng/ml.The patient's last total psa result from (b)(6) 2023 was 7.7 ng/ml.The customer had the patient redrawn because the medical provider questioned the low result of <0.1 ng/ml.The redraw result was 3.3 ng/ml.The customer's reference range is 0 - 4 ng/ml.No impact to patient management was reported.
Event or Problem Description
The customer stated that error 1044, unable to calculate result.Final rlu read is outside the specification of the lowest calibrator for total psa, was generated for three patient samples while using the alinity i total psa assay.Two of the three samples were tested on a different alinity i processing module and the same error occurred.The customer stated that two of the patients did have very low total psa results historically.The customer used new total psa calibrator lot 51060fn00 to resolve the issue and the three patient samples were retested.Patient (b)(6) and (b)(6): alinity i total psa result: <0.1 ng/ml.The results were expected to be low for both patients.No historical values were provided.Patient (b)(6): alinity i total psa result: <0.1 ng/ml; alinity i total psa result (different sample tube): 3.86 and 4.12 ng/ml; the patient's last total psa result from (b)(6) 2023 was 7.7 ng/ml.The customer had the patient redrawn because the medical provider questioned the low result of <0.1 ng/ml.The redraw result was 3.3 ng/ml.The customer's reference range is 0 - 4 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in house testing of a retained calibrator kit.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.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends regarding commonalities for complaint lot.Device history review did not identify any non-conformances or deviations with the complaint lot.Performance and accuracy testing was performed using an in-house retain kit of lot 48204fn00.Testing met acceptance criteria and the product is performing as expected.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i total psa calibrator lot 48204fn00 was identified.

• Brand Name: ALINITY I TOTAL PSA REAGENT KIT
• Common Device Name: 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: 18376168
• Report Number: 3008344661-2023-00200
• Device Sequence Number: 18070180
• Product Code: MTF
• UDI-Device Identifier: 00380740158316
• UDI-Public: 00380740158316
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P910007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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: 03/30/2024
• Device Catalogue Number: 07P92-21
• Device Lot Number: 51184FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I TOTAL PSA CAL, 07P92-01, 48204FN00.
• Patient Sex: Unknown