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 11/28/2022

Event Type  malfunction  

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 lead 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.As an interim action the disposal tubes will be checked at the supplier via a test procedure for incoming inspection and for in-process controls.As a long-term solution an alternate tubing material will be found that cannot get easily bent.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)(4).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 glp systems track is not yet distributed in the us.

Event Description

The customer reported samples were stuck in the waste chute of the glp loader module.The customer stated the whole waste chute was removed and the glp disposal tube was emptied.No further issues were reported.There was no patient involvement and no reported impact to patient management or user safety.

Event Description

The customer reported samples were stuck in the waste chute of the glp loader module.The customer stated the whole waste chute was removed and the glp disposal tube was emptied.No further issues were reported.There was no patient involvement and no reported impact to patient management or user safety.

Manufacturer Narrative

The long-term solution is to remove the tubing to utilize the full diameter of the disposal pathway, which will reduce the likelihood of tubes getting caught in the disposal pathway.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15992901
• MDR Text Key: 308074799
• Report Number: 3023268435-2022-00024
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup
• Report Date: 09/19/2023

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: 06T12-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/19/2023
• 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
• Treatment: GLP DISPOSAL TUBE, 06T24-01, UNKNOWN; GLP DISPOSAL TUBE, 06T24-01, UNKNOWN