MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I1000SR PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01L86-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
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 was cleaning the manifold nozzle of the wash station on the architect i1000sr module using a blood collection needle.After the use of the blood collection needle, the customer placed the needle into the protective cap and the needle popped out through the cap and stuck the customer¿s finger.The customer was proscribed retroviral medication to be taken after meals.There was no additional harm to the user reported.
Additional Manufacturer Narrative
A customer was performing troubleshooting due to the architect i1000sr, serial number (b)(6) generating error code 3700.When cleaning the wash zone manifold nozzle with a blood collection needle then trying to recap the blood collection needle, the needle came out through the cap and punctured his gloved hand.The injury to the operator is attributed to abnormal use as the operator did not follow the appropriate corrective actions.Return testing was not completed as returns were not available.The service history of the (b)(6) verifies no subsequent issues have been reported related to the current issue.A review of tracking and trending of the architect i1000sr did not identify any trends associated with the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the investigation the architect i1000sr, serial number (b)(6) is performing as intended, no systemic issue or deficiency of the architect i1000sr was identified.
Event or Problem Description
The customer was cleaning the manifold nozzle of the wash station on the architect i1000sr module using a blood collection needle.After the use of the blood collection needle, the customer placed the needle into the protective cap and the needle popped out through the cap and stuck the customer¿s finger.The customer was proscribed retroviral medication to be taken after meals.There was no additional harm to the user reported.

• Brand Name: ARCHITECT I1000SR 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: 22079157
• Report Number: 3016438761-2025-00312
• Device Sequence Number: 21010469
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 01L86-01
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown