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

Catalog Number	01L86-40
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The field service representative (fsr) (55-year-old male) reported a splash to the face from the architect i1000sr analyzer.The customer observed a drop hanging from the probe, which could not be resolved by wiping the drop off the probe.During troubleshooting the fsr removed tubing which caused a splash to the face and eyes.The fsr was wearing glasses.The fsr washed his face and flushed his eyes, but no other medical treatment was obtained.No further impact on patient management or user safety was reported.
Additional Manufacturer Narrative
A field service representative (fsr) reported a splash to the face while removing the architect probe tubing (06l04-02) from the architect i1000sr processing module serial number (b)(6).The fsr was wearing prescription glasses at the time not protective eyewear.The fsr washed his face and flushed his eyes.Return testing was not completed as returns were not available.An instrument service history search revealed no additional tickets related to the current issue.No contributing factors on or around the date of the complaint were found.There have been no subsequent contacts regarding splashing occurrence since the reported incident.A review of complaint and trending data for the architect i1000sr processing module did not identify any similar issues for splashing as described in this complaint.Additionally review of complaint and trending data associated with the arc probe tubing (06l04-02) did not identify an increase in complaint activity.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 available information, no systemic issue or deficiency of the architect i1000sr processing module for serial (b)(6) or the arc probe tubing was identified.
Event or Problem Description
The field service representative (fsr) (55-year-old male) reported a splash to the face from the architect i1000sr analyzer.The customer observed a drop hanging from the probe, which could not be resolved by wiping the drop off the probe.During troubleshooting the fsr removed tubing which caused a splash to the face and eyes.The fsr was wearing glasses.The fsr washed his face and flushed his eyes, but no other medical treatment was obtained.No further impact on patient management or user safety was reported.

• Brand Name: ARCHITECT I1000SR PROCESSING MODULE (INTEGRATED)
• 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: 21872822
• Report Number: 3016438761-2025-00235
• Device Sequence Number: 12728882
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 04/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 01L86-40
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2011
• 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: ARC BUFFER OUTLET, 01P12-01, UNKNOWN; ARC BUFFER OUTLET, 01P12-01, UNKNOWN
• Patient Age: 55 YR
• Patient Sex: Male