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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that she was splashed in the face while disconnecting a waste tubing from the external waste pump which was attached to the alinity ci-series system control module.The external waste pump was generating errors and leaking.The customer was in the process of replacing the external waste pump when the liquid from the waste tubing splashed her face.The customer was wearing a lab coat, gloves, and goggles at the time of the incident.She immediately washed her face and eyes with aqua dest (sterile water).The customer stated that she is doing fine.She did not seek any treatment other than washing her face and eyes with sterile water.There was no impact to patient management reported.
Additional Manufacturer Narrative
The customer was splashed in the face while attempting to connect a waste tubing on the replacement alinity ci external waste.The power to the external waste pump was on at the time the customer was connecting the waste tubing while the alinity analyzer was in a stopped status.The customer was wearing a lab coat, gloves, and goggles at the time of the splash.An instrument service history review for (b)(6) revealed no subsequent complaint regarding parts spraying fluid in the face.A review of tracking and trending of the alinity ci-series system control module did not identify any trends associated with the complaint issue.A review of tracking and trending for the alinity ci external waste did not identify any trends.The device history records were reviewed, and no non-conformances or potential non-conformances were identified.Labeling was reviewed and found to be adequate.Based on this investigation, no systemic issue or deficiency was identified for the alinity ci-series system control module, serial number (b)(6) or the alinity ci external waste.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported that she was splashed in the face while disconnecting a waste tubing from the external waste pump which was attached to the alinity ci-series system control module.The external waste pump was generating errors and leaking.The customer was in the process of replacing the external waste pump when the liquid from the waste tubing splashed her face.The customer was wearing a lab coat, gloves, and goggles at the time of the incident.She immediately washed her face and eyes with aqua dest (sterile water).The customer stated that she is doing fine.She did not seek any treatment other than washing her face and eyes with sterile water.There was no impact to patient management reported.

• 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: 20574225
• Report Number: 3016438761-2024-00638
• Device Sequence Number: 15580463
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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): Initial
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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 CI EXTERNAL WASTE, 04S74-01, UNKNOWN; ALNTY CI EXTERNAL WASTE, 04S74-01, UNKNOWN
• Patient Sex: Female