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

Catalog Number 03M74-01

Device Problem Leak/Splash (1354)

Patient Problem Eye Injury (1845)

Event Type  Injury  

Manufacturer Narrative

Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported an employee was splashed in the eye with patient samples.The gallon of buffer was overflowing from the architect i2000sr processing module and the employee slipped on the buffer while carrying a rack of samples.The samples were splashed in the employee's eyes.The employee received antiviral therapy due to the splash.No additional harm or injury to the employee was reported.The external water supply system (from (b)(4)) had a broken manometer.The water supply was sending water at a higher pressure to the iarm, which is connected to four architect instruments.The water kept coming in and the buffer on all four instruments started leaking at the same time.The patient/employee received antiviral therapy.

Manufacturer Narrative

The customer reported, that a broken manometer on the lab¿s elga-veolia water system caused water to enter the architect iarm water line at a high pressure.Resulting in simultaneous overflow from the 25l wash buffer containers of two i4000sr systems that were connected to the iarm.The customer¿s water system provider was contacted for repair of the broken manometer.And the abbott ambassador inspected the iarm and analyzers.No parts were replaced or adjusted on either the iarm or any of the analyzers.The architect i2000, serial number (b)(6), history log was reviewed, and found no errors related to the wash buffer inventory.And no errors generated by the iarm or on the date of the event.A review of the (b)(6) service history identified no contributing factors on or around the date of the complaint.There have been no subsequent contacts from the customer regarding a wash buffer overflow or any additional injuries.A review for similar complaints, identified no additional complaints related to a slip/fall injury or splashing/exposure incidents associated with wash buffer overflowing from the architect.Review of tracking and trending for the architect i2000sr did not identify any trends.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 investigation, no systemic issue or deficiency of the architect i2000sr processing module, serial number (b)(6) was identified.

• Brand Name: ARCHITECT I2000SR
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 10659811
• MDR Text Key: 216568648
• Report Number: 3016438761-2020-00243
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03M74-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention