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

Catalog Number	MDS4001LA
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when she went to the doctors, they compared the readings and her top number was off by 20, and bottom was off by 10.".
Additional Manufacturer Narrative
The customer reported readings off and said that when the blood pressure monitor was compared at the doctor's office, the top number was off by 20 and bottom was off by 10; the customer later sent email stating that the replacement is giving incorrect readings.Based on the review of the details provided for the complaint investigation, there were no samples, photos, videos, lot numbers, or other critical details provided, even after follow-ups with the customer.The complaint could not be confirmed, and medline was unable to confirm the complaint issue or that the product failed to meet specifications; without a sample received it is difficult to determine a true root cause for the reported issue.Additionally, there was no reported death or serious injury associated with this event, and if a sample, photo, and/or additional information becomes available, this complaint will be reopened to be further investigated.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: DBD-MONITOR,BP,AUTO,DIGITAL, LARGE ADULT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915494
• Report Number: 1417592-2026-52011
• Device Sequence Number: 5330466
• Product Code: DXN
• UDI-Device Identifier: 00884389106955
• UDI-Public: 00884389106955
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K193627
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MDS4001LA
• Was Device Available for Evaluation?: Yes
• 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: 12/04/2023
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown