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

Catalog Number 06Q20-01

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

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, glp module (list number 06q12-01), which has a same/similar component of the modular glp track system registered in the us, list number 04z96-520.Note: the glp aliquot module is not yet marketed in the us.

Event Description

The customer observed a burnt cable after hearing a loud bang coming from the glp storage module.The burnt cable was behind the front panel of the module and was burnt through.No injuries were reported.No impact to patient management was reported.

Manufacturer Narrative

The customer checked behind the panel in front of the glp storage module and found that the cable had burned through.It was noted that the cable was kinked, and no damage was found to any of the associated boards or other cables.No injury was reported to any users within the laboratory.A review of tracking and trending for the glp storage module did not identify any trends.Labeling was reviewed and found to be adequate.The abbott automation solutions (aas) technical group was able to determine that the cable was kinked and was suspected to contribute to the failure.Further inspection of the general cable routing concluded that this is a one-time occurrence.The 2023 ul certification memo indicates that abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.Based on the available information, no systemic issue or deficiency of the glp storage module was identified.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: 04z96-520 note: the glp aliquot module is not yet marketed in the us.

Manufacturer Narrative

Section h6: investigation findings code was updated from c13 operational problem identified to c1002 design error and investigation conclusions code was updated from d02 cause traced to component failure to d01 cause traced to device design.

Manufacturer Narrative

Further investigation identified that this incident was impacted by a potential issue in the cable routing and cable connection design of the archive i storage module.The cable routing and cable connection design in these modules may lead to damaged cables, exposing uninsulated wires.Glp trained service representatives accessing these cables while servicing the module may be exposed to these energized wires.Based on the investigation a deficiency was identified for the glp storage module (r) (list number 06q20-01), serial (b)(6).A product correction letter was issued to the customers with impacted modules to notify them of the potential issue.Laboratory users are instructed not to directly access the internal components of the archive i storage module as there is a group of cables at the top of the module that may have an exposed uninsulated wire.Customers are to contact their glp trained service representative to perform any internal service or maintenance.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 04z96-51.Note: the impacted product is not distributed in the us.

Manufacturer Narrative

Section g1: following information was updated.Contact office address 1 was updated from (b)(6).Contact office city was updated from (b)(6).Contact office postal code updated from (b)(6).Contact office country updated from (b)(6).Contact office first name updated from (b)(6).Contact office last name updated from (b)(6).Contact office email updated from(b)(6).Contact office phone number was updated from (b)(6).Contact office fax number was updated from (b)(6).

• Brand Name: GLP STORAGE 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: 16147730
• MDR Text Key: 307189736
• Report Number: 3023268435-2023-00002
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup,Followup
• Report Date: 02/02/2024

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: 06Q20-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 03/03/2023; 01/11/2024; 01/11/2024; 02/01/2024
• Supplement Dates FDA Received: 03/08/2023; 01/11/2024; 01/11/2024; 02/02/2024
• 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