MAUDE Adverse Event Report: ABBOTT MERLIN PROGRAMMER; NO MATCH

Model Number	3650
Medical Device Problem Codes	Break (1069); Smoking (1585); Noise, Audible (3273); Tactile Prompts/Feedback (4022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, smoke was observed coming out of the merlin programmer while in use.Additionally, it was noted the programmer was audibly buzzing, the touchscreen was no longer working as intended and the handle and printer were broken.The user of the merlin programmer and the patient were not harmed.The merlin programmer is no longer in use.
Additional Manufacturer Narrative
The field complaint of power issue and physical damage was verified as the event could be reproduced.Troubleshooting revealed faulty power supply and damaged printer, housing as the root-cause for this issue.

• Brand Name: MERLIN PROGRAMMER
• Common Device Name: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 20309440
• Report Number: 2017865-2024-65893
• Device Sequence Number: 15662957
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: (01)05414734500661(10)
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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
• Operator of Device: Health Professional
• Device Model Number: 3650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown