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

Catalog Number 06Q24-01

Device Problem Sharp Edges (4013)

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

Event Date 01/23/2023

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 cut himself on an unknown edge of the track element(glp buffer module).The customer was wearing gloves and was cleaning up spilled sample tubes.The cut was cleaned and disinfected.The technician went to have himself checked by a doctor.The involved samples were all negatively checked for hiv and hepatitis.The only treatment was cleaning and disinfecting at the lab.The technician had his blood drawn at the hospital and received no additional treatment.No intervention beyond first aid (washing with soap and water) was necessary.No impact to patient management reported.

Manufacturer Narrative

The field service representative (fsr) stated that multiple samples were spilled by the glp buffer module (bm) (list number 06q24-01), serial (b)(6), during operation.One of the operators placed the module offline and cleaned the area.During clean up, the operator cut their hand on an unknown edge of the track element.A review of tracking and trending for the glp buffer module (bm) (list number 06q24-01) did not identify any trends.Labeling was reviewed and found to be adequate.The abbott automation solutions (aas) technical group performed an investigation based on the complaint information and were unable to determine where the cut originated from.Further information and photos were requested by aas to investigate the issue.No track elements could be identified to be designed as sharp and stated that general operator safety should be observed when operating the glp module.Based on the available information, no deficiency could be identified; therefore, no further actions are being taken.Based on the available information, no systemic issue or deficiency of the glp buffer module (bm) 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: 16278696
• MDR Text Key: 308917284
• Report Number: 3023268435-2023-00006
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/02/2023

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: 01/24/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 02/22/2023
• Supplement Dates FDA Received: 03/02/2023
• 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 Sex: Male