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	Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/03/2026
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.Section a patient information: refer to section b5 for complete patient information.All available patient information was provided, no additional patient information was available.
Event or Problem Description
While replacing parts on the i1000sr processing module, the field service engineer (fse) sustained a 2-inch cut on his lower right palm.Cut allowed to bleed and washed with soap and water.Did not require stitches.Currently bandaged and healing.The field service engineer (fse) notified occupational health and went to his pcp and is being tested for bloodborne diseases hiv and hepatitis a/b/c as well as tetanus.He will be tested again in one month and three months to confirm immune status.As a precaution, he is being prescribed with prophylaxis.The individual was started on prophylaxis.
Event or Problem Description
While replacing parts on the i1000sr processing module, the field service engineer (fse) sustained a 2-inch cut on his lower right palm.Cut allowed to bleed and washed with soap and water.Did not require stitches.Currently bandaged and healing.The field service engineer (fse) notified occupational health and went to his pcp and is being tested for bloodborne diseases hiv and hepatitis a/b/c as well as tetanus.He will be tested again in one month and three months to confirm immune status.As a precaution, he is being prescribed with prophylaxis.The individual was started on prophylaxis.
Additional Manufacturer Narrative
Sections d3 email and g1 mfg site email were updated.The field service engineer (fse) sustained a 2-inch cut on his lower right palm while working on a i1000sr processing module, serial number (b)(6).The fsr¿s hand slipped while attempting to remove the cable plug near the top of the cable, pipettor lls z.The cable, pipettor lls z is considered the likely cause of the incident.Information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The instrument service history review revealed no additional tickets associated with personal injury.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 tracking and trending of the architect i1000sr processing module and cable, pipettor lls z 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 available information, no systemic issue or deficiency of the architect i1000sr processing module and cable, pipettor lls z was 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: 24604820
• Report Number: 3016438761-2026-00137
• Device Sequence Number: 18756565
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 04/23/2026

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: 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: 02/27/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2013
• 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: Male