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

Catalog Number 06T12-01

Device Problem Product Quality Problem (1506)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

The field service representative (fsr) stated that a jam was found in the glp disposal tube (list number 06t24-01) for the glp loader module (lm), sn(b)(4).The fsr removed the tubes from waste disposal, which resolved the issue.There was no patient involvement and no reported impact to patient management or user safety.

Manufacturer Narrative

During investigation, it was found that the reason the 16 mm sample tubes were getting stuck in the glp disposal tube is because the disposal tube was found to be deformed and not quite round.The deformed disposal tube led to sample tubes getting stuck causing back-up and potential spillage of the sample tubes and its contents.The cause for the deformed tube was determined to be related to the material of the disposal tubing (pvc).The material was found to be too flexible.Because the tubing is deformed and flexible, they become bent when being inserted, resulting in less space for the sample tubes to slide into the waste bin.To reduce the likelihood of the tubes getting caught in the disposal pathway, the tubing is being removed in order to use the full diameter of the disposal pathway.Based on the investigation, a deficiency was identified with the glp disposal tube (list number 06t24-01) for the glp loader module (lm), serial (b)(6).This report is being filed on an international product, glp loader module, list number 06t12-01, which has a same/similar component of the modular glp systems track registered in the us, list number 04z96-51.Note: the impacted product is not distributed in the us.

• Brand Name: GLP LOADER 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18861598
• MDR Text Key: 337296133
• Report Number: 3023268435-2024-00009
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/07/2024

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: 06T12-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/07/2024
• 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
• Treatment: GLP DISPOSAL TUBE, 06T24-01, UNKNOWN