MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I2000SR; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03M74-01
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
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 observed the top cover of the architect i2000sr analyzer would not remain in the upright position.The customer stated that there have been no injuries due to the cover not staying up.There was no injury reported and no impact to patient management.
Additional Manufacturer Narrative
The field service representative (fsr) tightened the hinge, top front cover (rohs)_part number 7-76748-01 and deemed the part the likely cause.The issue was resolved with the tightening of the hinge, top front cover (rohs).There have been no subsequent contacts from the customer regarding covers post service¿s intervention.A review of the architect architect i2000sr, serial # (b)(6) service history found no contributing factors on or around the date of the complaint.A review of tracking and trending of the hinge, top front cover (rohs)_part number 7-76748-01 did not identify any trends associated with the complaint issue.A review of historical data revealed no trends, systemic issues, or related nonconformances.The architect system operations manual addresses proper and safe operation and function of the i2000sr system.The architect i-system service and support manual provide instructions for removal and replacement of the hinge, top front cover.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for either the architect i2000sr, serial # (b)(6) , or hinge, top front cover (rohs)_part number 7-76748-01.
Event or Problem Description
The customer observed the top cover of the architect i2000sr analyzer would not remain in the upright position.The customer stated that there have been no injuries due to the cover not staying up.There was no injury reported and no impact to patient management.

• Brand Name: ARCHITECT I2000SR
• 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: 20881192
• Report Number: 3016438761-2024-00712
• Device Sequence Number: 21009947
• Product Code: JJE
• UDI-Device Identifier: 00380740023386
• UDI-Public: (01)00380740023386
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 01/23/2025

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: 03M74-01
• 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: 11/27/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2018
• 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: HINGE, TOP FRONT COVER (ROHS), 7-76748-01, UNKNOWN
• Patient Sex: Unknown