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

Catalog Number 06Q42-01

Device Problem Application Program Version or Upgrade Problem (2881)

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

Event Date 01/17/2023

Event Type  malfunction  

Event Description

The customer reported hemoglobin a1c results not consistent and questioned by the physician on alinity c processing module which connected with glp track system.The hemoglobin a1c specimens started centrifuge on glp track system after software upgrade.The customer has setting on centrifuge that the hemoglobin a1c specimens should not centrifuge before analysis.The customer noticed that precondition was not there on centrifuge after software upgrade.The precondition for the hemoglobin a1c specimens changed before testing during the software update of the glp track system.The software upgrade was performed by the abbott fsr.The results provided were: sid (b)(6).Unspun specimen results 4.8 to 13.2% /spun specimen 4.9 to > 14% after the precondition reset on centrifuge the hemoglobin a1c specimen stop centrifuge.There was no reported impact to patient management.

Manufacturer Narrative

Complete information for section a patient information, 1.Patient identifier sid (b)(6).Updated postal code (b)(6).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, product name (ex.Glp centrifuge module), list number 6q42, 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

The glp technical group performed a review of the issue.Based on the available information within the complaint text and ticket system, glp technical group concluded there were no other tickets found to be similar to the current issue.The abbott automation solutions (aas) technical group performed an investigation based on the complaint information and analysis of the track workflow manager (twm) logs provided.The aas technical team found that the issue was not related to the glp system track but to a missing configuration step in the twm; log review indicated the centrifuge configuration was changed by the customer on january 12, 2023, after the software upgrade.The complaint information was reviewed and determined the event was related to use error.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.Use error caused the issue as the centrifuge configuration was changed by the operator that led to hba1c samples to be centrifuged.No product deficiency was identified.

• Brand Name: GLP TRACK END
• 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: 16335911
• MDR Text Key: 309169966
• Report Number: 3023268435-2023-00007
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/06/2023

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: 06Q42-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/06/2023
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1