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

Catalog Number	01L86-84
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	12/28/2024
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.
Event or Problem Description
The customer received strong electric shock on her left hand when trying to load afp reagent on rsh of architect i1000sr processing module.The customer feels tingling and numb on her arm.The electrocardiogram (ekg or ecg) performed on the user on (b)(6) 2024.The user is doing ok, and her arm is ok and there is no numbness.No further impact to patient management.There was no patient involvement or facility damage reported.
Additional Manufacturer Narrative
During the requested site visit, the field service engineer (fse) inspected the instrument onsite and checked the i1000sr electrical components and grounding but found no issue.The service representative documented the uninterruptible power supply (ups) was in bypass mode instead of line mode; voltages were measured and as expected.No architect parts were replaced or adjusted.The instrument service history review revealed no additional service tickets associated documenting shock associated with the architect i1000sr, serial # (b)(6) analyzer.A review of complaint and trending data for the architect i1000sr processing module did not identify any similar issues as described in this complaint.The architect system operations manual addresses electrical hazard awareness, operator responsibility, safety symbols and classification, power distribution, and system specifications.A review of labelling adequately addresses sample results observed problems for erratic / discrepant results.Based on the investigation no product deficiency was identified for the architect i1000sr processing module, serial number (b)(6).
Event or Problem Description
The customer received strong electric shock on her left hand when trying to load afp reagent on rsh of architect i1000sr processing module.The customer feels tingling and numb on her arm.The electrocardiogram (ekg or ecg) performed on the user on (b)(6) 2024.The user is doing ok, and her arm is ok and there is no numbness.No further impact to patient management.There was no patient involvement or facility damage reported.

• Brand Name: ARCHITECT I1000SR
• 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: 21169166
• Report Number: 3016438761-2025-00033
• Device Sequence Number: 19984357
• Product Code: JJE
• UDI-Device Identifier: 00380740116941
• UDI-Public: (01)00380740116941
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: 01L86-84
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2013
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown