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	Leak/Splash (1354)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	09/20/2025
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.E1 - postal code: a leading zero was added to the field because the system requires a minimum of 5 digits in the postal code field.
Event or Problem Description
The customer reported an issue with the architect i1000sr analyzer.The buffer bottle sensor was not being detected by the instrument; therefore, the instrument went into stop mode.The field service engineer arrived onsite and while inspecting the fluidics board, the hc peristaltic tubing came loose and splashed fluid onto the skin of the fse¿s face.The fse was wearing personal protective equipment at the time of the incident.After the incident, the fse immediately proceeded to wash their face with soap and water.After completing the service call, the fse notified the occupational risk insurer (art) and received the following instructions.The fse was scheduled for an appointment on (b)(6) 2025, at 1:00 pm to have blood drawn and to start lisotyr and dolufevir (anti-retroviral medication).The fse is doing fine and is still working while taking the medication.There was no further impact to patient management or user safety reported.
Event or Problem Description
The customer reported an issue with the architect i1000sr analyzer.The buffer bottle sensor was not being detected by the instrument; therefore, the instrument went into stop mode.The field service engineer arrived onsite and while inspecting the fluidics board, the hc peristaltic tubing came loose and splashed fluid onto the skin of the fse¿s face.The fse was wearing personal protective equipment at the time of the incident.After the incident, the fse immediately proceeded to wash their face with soap and water.After completing the service call, the fse notified the occupational risk insurer (art) and received the following instructions.The fse was scheduled for an appointment on (b)(6) 2025, at 1:00 pm to have blood drawn and to start lisotyr and dolufevir (anti-retroviral medication).The fse is doing fine and is still working while taking the medication.There was no further impact to patient management or user safety reported.
Additional Manufacturer Narrative
A field service representative (fsr) was troubleshooting an issue reported by the customer in which the buffer bottle sensor was not being detected by the architect i1000sr, serial number (b)(6), therefore stopping operation of the instrument.To resolve the issue, the fsr replaced the bd, fluidics distribution (rohs)_part number 7-98010-02 and started the instrument up.While checking/verifying the boards led lights of the newly installed board, the tubing from the head waste pump (rohs) came off and the fsr was sprayed with liquid.The fsr immediately washed his face with soap and water.The fsr was wearing personal protective equipment at the time the incident occurred.The fsr contacted occupational risk insurer (art) and was prescribed anti-retroviral medication.A review of the architect i1000sr, serial number (b)(6) service history, revealed no additional issues of splashing from parts reported on the (b)(6).A review of tracking and trending data associated with the head, waste pump (rohs)_part number 7-200378-01 did not identify any related trends.A review of tracking and trending did not identify any trends for the architect i1000sr with regards to the current issue.A review of the manufacturing documentation did not identify any nonconformances associated with the complaint issue.The i1000sr service and support manual provides adequate labeling with regards to the removal and replacement of the fluidics distribution board and waste pump head.The architect operations manual also provides adequate labeling with regards to the biological and chemical safety hazards that includes wearing personal protective equipment (ppe) and safety awareness where hazards may exist.Based on the investigation, no systemic issue or product deficiency of the architect i1000sr, serial number (b)(6) or the head, waste pump (rohs) were identified.

• 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: 23199182
• Report Number: 3016438761-2025-00574
• Device Sequence Number: 10081080
• 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): 01/23/2026

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: 09/20/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 01/23/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEAD, WASTE PUMP (ROHS), 7-200378-01, UNKNOWN; HEAD, WASTE PUMP (ROHS), 7-200378-01, UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown