MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MONITOR,BP,AUTO,DIGITAL,ADULT

Catalog Number	MDS3001
Medical Device Problem Codes	High Readings (2459); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Other
Event or Problem Description
It was reported that "the blood pressure monitor is off.Clinic informed its off by 20 points.The clinic tested her and noiced it was off.".
Additional Manufacturer Narrative
The customer reported receiving a medline bp monitor that is giving readings off; checked twice with medline bp monitor: 141/48, 136/49 and twice with clinic monitor: 117/68, 116/66, and the discrepancy is about 20mmhg for both the systolic and diastolic readings.We received 1 ea automatic digital blood pressure monitor; upon visual inspection there were no noticeable defects or cosmetic damage, four control aa batteries were then inserted, and functional testing was performed at 120±5 /80±5 @ 80±5bpm and 150±5/100±5 @ 80±5bpm, with values recorded of 122/81 @ 79bpm and 152/102 @ 80bpm.These are within acceptable ranges, and the complaint was not confirmed.No trends were identified for the specified material number and its corresponding defect type, and there has been no change to the reportability decision associated with this complaint.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: MONITOR,BP,AUTO,DIGITAL,ADULT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50918174
• Report Number: 1417592-2026-52405
• Device Sequence Number: 20278253
• Product Code: DXN
• UDI-Device Identifier: 10080196525140
• UDI-Public: 10080196525140
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Catalogue Number: MDS3001
• Device Lot Number: 43324120001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/05/2026
• 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: 12/24/2025
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 124 LB