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

Catalog Number 01L86-01

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported that during a repair on an architect i1000sr, there was a splash that occurred to an operator¿s eye.It was reported that the operator was observing the repair and was not wearing eye protection at the time of the event.The operator was instructed to flush the impacted eye with water and to seek a medical evaluation.The medical evaluation recommended to monitor the eye.It was confirmed that no medications were recommended from the medical evaluation.

Manufacturer Narrative

The architect i1000sr serial number (b)(6) was inspected, and the field service engineer (fse) determined that the assy, vacuum accumulator, complete (rohs) required replacement.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of tracking and trending did not identify a trend for the assy, vacuum accumulator, complete (rohs) or architect system as with regards to the customer reported event.A review of the manufacturing documentation did not identify any related non-conformances or potential non-conformances related to the assy, vacuum accumulator, complete (rohs) and customer reported event.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, there was no systemic issue or deficiency identified.

Event Description

The customer reported that during a repair on an architect i1000sr, there was a splash that occurred to an operator¿s eye.It was reported that the operator was observing the repair and was not wearing eye protection at the time of the event.The operator was instructed to flush the impacted eye with water and to seek a medical evaluation.The medical evaluation recommended to monitor the eye.It was confirmed that no medications were recommended from the medical evaluation.

• Brand Name: ARCHITECT I1000SR
• Type of Device: 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: 18608566
• MDR Text Key: 334261379
• Report Number: 3016438761-2024-00058
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01L86-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1