MAUDE Adverse Event Report: ABBOTT AUTOMATION SOLUTIONS GMBH GLP TRACK END; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 06Q42-01

Device Problem Unintended Collision (1429)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the operator was completing routine work and bumped into the glp equipment of the alinity ci series system.The operator was holding samples from several patients, causing the samples to accidentally fall on her body and face.The operator used the eyewash and sinks for self-cleaning and was sent to the hospital.The operator also had a shower, flushed eyes, changed clothes, is being followed by hospital every six months, serology tests has been done, she took medicine to prevent any other problem (medication names: dolutegravir sódico, fumarato de tenofir, and retrovirall de anti-hiv).

Manufacturer Narrative

The field service representative (fsr) stated that the operator bumped into the track end cover r (part number g-41751-01) for the glp track end, serial (b)(4), during the middle of the glp track installation process.The fsr specified that the operator was holding several patient samples when the arm hit against the track section for the alinity ci series instrument, causing the samples to splash on the operator¿s body and face.The abbott automation solutions (aas) technical group performed an investigation based on the complaint information.Aas was able to determine that the glp module and track did not cause or contribute to the event and a malfunction was not identified.Since no issues could be identified with the glp track, no further actions were performed.Current labeling provides field service and operators the safety information and advises caution to the user involving the risk of contamination and injury due to inattentive handling or not observing proper personal protective equipment (ppe).Trending review did not identify any trends for the issue under review.No malfunction was identified.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.The issue is considered a use error as the customer caused the mishandling of the sample tubes.The track end cover or the glp track end did not cause or contribute to the event.This issue was previously reported under mdr number 3016438761-2023-00025-00 under a different suspect device.All further information will be documented under this mdr 3023268435-2023-00012-00.

• Brand Name: GLP TRACK END
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT AUTOMATION SOLUTIONS GMBH; sachsenkamp 5; hamburg 20097 ; GM 20097
• Manufacturer (Section G): ABBOTT AUTOMATION SOLUTIONS GMBH; sachsenkamp 5; hamburg 20097 ; GM 20097
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16479288
• MDR Text Key: 310623735
• Report Number: 3023268435-2023-00012
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K213486
• 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
• Report Date: 03/03/2023

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: 06Q42-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention