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 11/30/2023

Event Type  malfunction  

Manufacturer Narrative

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.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a secondary tube was incorrectly labeled with the wrong patient¿s name by the glp aliquot module.It was noted that the patient¿s name for sid (b)(6) was long.When the glp aliquot module generated a secondary tube for sid (b)(6), the wrong patient¿s name was associated with this secondary tube.There was no test performed on the secondary tube.No impact to patient management was reported.

Manufacturer Narrative

Section h10: list number for glp track system registered in the us was corrected from 04z965-20 to 04z96-51.

Event Description

The customer observed a secondary tube was incorrectly labeled with the wrong patient¿s name by the glp aliquot module.It was noted that the patient¿s name for sid (b)(6) was long.When the glp aliquot module generated a secondary tube for sid (b)(6), the wrong patient¿s name was associated with this secondary tube.There was no test performed on the secondary tube.No impact to patient management was reported.

Manufacturer Narrative

The field service representative (fsr) reported that the wrong patient¿s name was printed on to the secondary sample tube label for the glp aliquot module (am), serial (b)(6).As the patient¿s name was long, no tests were performed for the secondary tube and no impact to patient management was reported.During an investigation into this issue, it was found that the glp am was not upgraded to software version 2.1.1 for aliquot module at the time of the incident.Further investigation identified 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).A product correction letter was issued on 15aug2023 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 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 module (list number 06q12-01), which has a same/similar component of the modular glp track system registered in the us, list number 04z965-20.Note: the impacted product is not distributed in the us.

• 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: 18380028
• MDR Text Key: 331367397
• Report Number: 3023268435-2023-00043
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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
• Date Manufacturer Received: 01/17/2024
• 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