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

Catalog Number 06Q12-01

Device Problem Patient Data Problem (3197)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

The customer observed the glp aliquot module printed the wrong analyzes on the secondary tube label due to analyze had more than 49 characters.The customer discovered the issue prior to any testing was completed, however it caused a delay in the reporting of results.All tests were done correctly.There was no impact to patient management.

Manufacturer Narrative

All available patient information was included, no additional patient information was available.During an investigation into this issue, it was found that free text fields for secondary tube labels are limited to 49 characters.When 50 characters or more are used, the aliquot module (am) may print labels with text information from other labels.Although the text information is incorrect, the barcode readable information remains correct.Based on the available information, a deficiency was identified for the glp aliquot module (am) (list number 06q12-01) as it did not perform per the 12260 (aliquot module) service manual (06/17/2022).A product correction letter was issued on (b)(6) 2023 to all customers with installed glp track and aliquot module (am) (list number 06q12-01), notifying them of the potential performance issue.Additionally, the product correction letter informs the customer of the following necessary action that is required until the software version is updated.Abbott service representative will contact the customer to schedule a mandatory upgrade when the software is available for each module.This report is being filed on an international product, glp aliquot module, list number 06q12-01, which has a same/similar component of the modular glp systems track registered in the us, list number 04z96-51.

• Brand Name: GLP ALIQUOT 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: 18725632
• MDR Text Key: 335614137
• Report Number: 3023268435-2024-00007
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 02/16/2024

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: 06Q12-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/16/2024
• 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