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 08/09/2023

Event Type  malfunction  

Event Description

The customer observed that the patient¿s name or the assay name on the barcode label was incorrectly printed on the glp aliquot module.It was noted that when the patient¿s name is too long, the name of the previous patient may appear on the barcode label.This also happened if the assay name is too long.The information contained within the barcode was correct and the automation system processed the sample correctly.It is only when the customer visually looks at the barcode label that the patient¿s name or the assay name was incorrect.The customer provided sid (b)(6) as an example of this incident.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a1 patient identifier is (b)(6).

Event Description

The customer observed that the patient¿s name or the assay name on the barcode label was incorrectly printed on the glp aliquot module.It was noted that when the patient¿s name is too long, the name of the previous patient may appear on the barcode label.This also happened if the assay name is too long.The information contained within the barcode was correct and the automation system processed the sample correctly.It is only when the customer visually looks at the barcode label that the patient¿s name or the assay name was incorrect.The customer provided sid (b)(6) as an example of this incident.No impact to patient management was reported.

Manufacturer Narrative

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), sn (b)(6) as it did not perform per the 12260 (aliquot module) service manual (06/17/2022).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 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.Note: the glp systems track is not yet marketed 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17578602
• MDR Text Key: 321511230
• Report Number: 3023268435-2023-00030
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: LU
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• 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: 08/30/2023
• 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