MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY CI-SERIES SYSTEM CONTROL MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03R70-01
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed phosphorus controls and patient specimens ran on expired phosphorus reagent without any flagging with results from alinity ci processing module.The customer noticed the phosphorus2 reagent lot number expired on 28sep2024.The controls and patient specimens ran on (b)(6) 2024 from expired phosphorus2 reagent without any flagging with results.The results provided were: on (b)(6) 2024 sid (b)(6) initial=1.3 mg/dl /repeated after new reagent lot number of phosphorus reagent=1.3 mg/dl.Sid (b)(6) initial=2.7 mg/dl /repeated on after new reagent lot number of phosphorus reagent=2.8 mg/dl there was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).
Event or Problem Description
The customer observed phosphorus controls and patient specimens ran on expired phosphorus reagent without any flagging with results from alinity ci processing module.The customer noticed the phosphorus2 reagent lot number expired on 28sep2024.The controls and patient specimens ran on (b)(6)2024 from expired phosphorus2 reagent without any flagging with results.The results provided were: on (b)(6)2024, sid (b)(6), initial=1.3 mg/dl /repeated after new reagent lot number of phosphorus reagent=1.3 mg/dl.Sid (b)(6), initial=2.7 mg/dl /repeated on after new reagent lot number of phosphorus reagent=2.8 mg/dl there was no reported impact to patient management.
Additional Manufacturer Narrative
An instrument service history review for alinity ci-series system control module serial number (b)(6), no contributing factors to the current complaint issue and no subsequent tickets associated with the complaint issue.A review of tracking and trending data did not identify any related trends for the product for the issue.The alinity ci-series operations manual provides customers with adequate information on how to configure assay and calibrator settings, add, delete, or edit smart wash settings, configure result settings, and configure retest rules.It also contains instructions and information on configuring reagent and diluent options and supplying low alerts.The manual provides descriptions of cartridge statuses.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the alinity ci-series system control module (scm), serial number (b)(6) was identified.

• Brand Name: ALINITY CI-SERIES SYSTEM CONTROL MODULE
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 20502883
• Report Number: 3016438761-2024-00614
• Device Sequence Number: 20906919
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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 Catalogue Number: 03R70-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNT CI SW V3.5.0, 04V20-24, (B)(6); ALNT CI SW V3.5.0, 04V20-24, (B)(6)
• Patient Sex: Unknown