MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I STAT HIGH SENSITIVITY TROPONIN-I; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number	04Z21-35
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
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.Section a1 patient identifier complete sid: (b)(6).
Event or Problem Description
The customer reported a falsely elevated alinity i stat high sensitivity troponin-i result on a female patient.The following results were provided: (b)(6) 2024 03:58 pm sid (b)(6) 184.3 ng/l, repeated same sample on another alinity on (b)(6) 2024 = < 4 ng/k; new sample on (b)(6) 2024 17:10 sid (b)(6) = < 4 ng/l.New sample on (b)(6) 2024 18:26 sid (b)(6) = < 4 ng/l.Reference range: female <13 ng/l.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a search for similar complaints, and the review of complaint text, trending data, labelling, accuracy testing, and device history records.Returns were not available.The review of historical performance of reagent lot 58191ud00, was completed.Trending review determined no trends for the issue for the product.Device history record review on lot 58191ud00 did not show any potential non-conformances, or deviations.Accuracy of the assay has been evaluated with a retained in-house kit and met all specifications, confirming that this lot is meeting the alinity i stat high sensitive troponin-i product requirements.Labelling was reviewed and found to adequately address the issue under review.Based on the investigation, the alinity i stat high sensitivity troponin-i lot number 58191ud00 identified no systemic issue and/or product deficiency.
Event or Problem Description
The customer reported a falsely elevated alinity i stat high sensitivity troponin-i result on a female patient.The following results were provided: on (b)(6) 2024 03:58 pm sid (b)(6) 184.3 ng/l, repeated same sample on another alinity on (b)(6) 2024 = < 4 ng/k.New sample on (b)(6) 2024 17:10 sid (b)(6) = < 4 ng/l.New sample on (b)(6) 2024 18:26 sid (b)(6) = < 4 ng/l.Reference range: female <13 ng/l.No impact to patient management was reported.

• Brand Name: ALINITY I STAT HIGH SENSITIVITY TROPONIN-I
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18824973
• Report Number: 3005094123-2024-00088
• Device Sequence Number: 3047635
• Product Code: MMI
• UDI-Device Identifier: 00380740194079
• UDI-Public: 00380740194079
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K202525
• 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): 03/18/2024

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: 04/30/2024
• Device Catalogue Number: 04Z21-35
• Device Lot Number: 58191UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2023
• 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)
• Patient Sex: Female