MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) INPECO SYSTEM APS IOM; AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM

Catalog Number 03L55-01

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported she was splashed in the eyes/face when removing the input/output tray on the accelerator aps system.The clamp broke and she was splashed with patient specimen.She was wearing a protective n95 mask, however, the fluid still came in contact with her eyes and face.The patient will undergo serology checkups as a preventative measure.No further injury, harm, or medical intervention was reported.

Manufacturer Narrative

The investigation included a search for similar complaints, the review of complaint text, trending data, and labeling review.Labelling was reviewed and the accelerator aps operations manual states the function of the input/output module and describes the routine racks in relation to the input/output module.Trending data was reviewed, and it was determined that there were no trends related to the issue for the product.The device history record review did not identify any issues with the accelerator aps and the complaint issue.The investigation to determine how the rack handle unexpectedly detached from the rack body causing it to fall, included a review of the pictures of the rack, and the three pins that keep the handle attached to the rack body were also examined.It was concluded that the three pins that keep the handle attached to the rack seemed whole but could only assume that the rack might have been more worn out than previously thought.It is recommended to replace the rack and to check the mechanical status of all racks to avoid similar scenarios in the future.Based on the investigation, no systemic issue or deficiency of the accelerator aps system routine rack of the inpeco system was identified.

• Brand Name: INPECO SYSTEM APS IOM
• Type of Device: AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 10382576
• MDR Text Key: 232825540
• Report Number: 3016438761-2020-00162
• Device Sequence Number: 1
• Product Code: JQP
• 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: 11/02/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 03L55-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1