MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C16000 PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03L77-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that she punctured her thumb with a metal nozzle while replacing the dry tip during monthly maintenance on the architect c16000 processing module.She was wearing gloves at the time of the incident.The customer confirmed that the puncture was bleeding; however, the area was cleaned with water.The customer went to the emergency room, where she received a tetanus shot.Blood was also drawn for hepatitis b testing.The customer is doing ok.There was no patient involvement.
Event or Problem Description
The customer stated that she punctured her thumb with a metal nozzle while replacing the dry tip during monthly maintenance on the architect c16000 processing module.She was wearing gloves at the time of the incident.The customer confirmed that the puncture was bleeding; however, the area was cleaned with water.The customer went to the emergency room, where she received a tetanus shot.Blood was also drawn for hepatitis b testing.The customer is doing ok.There was no patient involvement.
Additional Manufacturer Narrative
The customer stated that she punctured her thumb with a metal nozzle while replacing the dry tip during monthly maintenance on the architect c16000 processing module.She was wearing gloves at the time of the incident.An instrument service history review for architect (b)(6) revealed no additional tickets associated with the adverse event described in the current complaint.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of complaint and trending data for the architect c16000 processing module did not identify any similar issues as described in this complaint.Additionally, review of complaint and trending data associated with the nozzle, dry (rohs) and the cc cuv dry tip did not identify an increase in complaint activity.A review of labeling was performed and found to be adequate.Based on the information on this complaint, the adverse event described in this complaint is related to correct use.Based on the investigation, the device met performance specification and performed as intended at the customer site; therefore, there is no systemic issue or deficiency with the architect c16000 processing module, serial number (b)(6), or nozzle, dry (rohs) and the cc cuv dry tip.

• Brand Name: ARCHITECT C16000 PROCESSING 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: 22071362
• Report Number: 3016438761-2025-00307
• Device Sequence Number: 15628745
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 03L77-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown