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

Catalog Number 06Q24-01

Device Problem Smoking (1585)

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

Event Date 08/28/2022

Event Type  malfunction  

Event Description

The customer observed smoking coming from the glp buffer module power supply unit.The customer was having electrical maintenance performed on their infrastructure and a short circuit occurred.Smoke was then seen coming from the glp buffer module power supply unit.No injuries were reported.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, glp buffer module, list number 06q24-01, which has a same/similar component of the modular glp systems track registered in the us, list number 04z96-51.Note: the glp systems track is not yet marketed in the us.

Manufacturer Narrative

This follow up is being submitted to include the initial coding in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

Manufacturer Narrative

The field service representative (fsr) inspected the instrument and determined that the supply unit assy short-circuited which caused it to emit smoke.The supply unit assy was returned for investigation with the abbott automation solutions (aas) technical group.No evidence of smoke or smoke residue was found on the part.A blown fuse was found during investigation and replacement of the fuse showed all electrical and functional tests passed.The 2022 ul certification memo indicates that abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.A review of tracking and trending for the supply unit assy 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 available information, no systemic issue or deficiency of the glp buffer module or the supply unit assy was identified.

• Brand Name: GLP BUFFER MODULE
• 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: 15353543
• MDR Text Key: 305587208
• Report Number: 3023268435-2022-00006
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 11/17/2022

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: 06Q24-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2022
• Initial Date FDA Received: 09/03/2022
• Supplement Dates Manufacturer Received: 09/06/2022; 11/14/2022
• Supplement Dates FDA Received: 09/24/2022; 11/18/2022
• 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