MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C8000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 01G06-97

Device Problem Leak/Splash (1354)

Patient Problem Eye Injury (1845)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer experienced a splash to their eye when cleaning out the waste pump line on the architect c8000 analyzer.The customer went to the eye doctor: eyes were cleaned and an antibiotic was started.

Manufacturer Narrative

H6.Health effect impact code: f26.Component code: g03001.D8.Was this device service by a third party? no.Use error may have contributed to the complaint issue regarding the use of personal protective equipment (ppe) while using the product.The abbott field service representative (fsr) inspected the analyzer and confirmed that the obstruction and the leaking were limited to the customer¿s waste line.The fsr cleaned the waste line and all the external waste pump lines which resolved the issue.No concerns were identified, and no parts were replaced; however, the fsr indicated that significant steps were not performed correctly by the customer.No protective eyewear as per product labeling was in use at the time of the incident.Additionally, the customer was not following a procedure and the customer pulled the external waste pump line out without turning off the external waste pump power switch.No trends or similar issues for splashing/exposure as described in this ticket were identified.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Labeling was reviewed and found to adequately address the biological and chemical safety hazards that may exist including the wearing of personal protective equipment (ppe).Based on the investigation no systemic issue or product deficiency was identified.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• Brand Name: ARCHITECT C8000
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 11290409
• MDR Text Key: 230694714
• Report Number: 3016438761-2021-00039
• 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,Followup
• Report Date: 06/17/2021

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: 01G06-97
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/07/2021
• Supplement Dates Manufacturer Received: 03/25/2021; 06/15/2021
• Supplement Dates FDA Received: 03/26/2021; 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention