MAUDE Adverse Event Report: ABBOTT MEDICAL CARDIOMEMS¿ HOSPITAL SYSTEM; SYSTEM, HEMODYNAMIC, IMPLANTABLE

Model Number	CM3100
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fa-q125-hf-1 cm3100 duplicated patient profile in hf cloud notice issued by abbott on 30jan2025.Capa 139725 has been initiated to investigate this issue.
Event or Problem Description
The device is included in the fa-q125-hf-1 cm3100 duplicated patient profile in hf cloud initiated on (b)(6) 2025.Abbott r&d internal testing and code review identified an issue where the readings from one cm3100 system session for one patient (b)(6) were incorrectly reported under a different patient (patient b).No patient injury was reported.The issue is currently under investigation.(b)(4) was created for the second patient (b)(6).

• Brand Name: CARDIOMEMS¿ HOSPITAL SYSTEM
• Common Device Name: SYSTEM, HEMODYNAMIC, IMPLANTABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 387 technology circle nw suite 500; atlanta GA 30313
• Manufacturer (Section G): ABBOTT MEDICAL; 387 technology circle nw suite 500; atlanta GA 30313
• Manufacturer Contact: fredric gold ; 168 middlesex turnpike; burlington, MA 01803 ; 6517565400
• MDR Report Key: 24435663
• Report Number: 3004936110-2026-00282
• Device Sequence Number: 13322918
• Product Code: MOM
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P100045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: CM3100
• Device Catalogue Number: CM3100
• Device Lot Number: 8577205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q125-HF-1
• Patient Sequence Number: 1
• Patient Sex: Unknown