MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; METER,GLUCOSE,EVENCARE PROVIEW,PROF.USE

Catalog Number	MPH4540
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "batteries don't last.The display gradually goes dark.Does not have a consistent reading, which puts the whole machine in question.".
Additional Manufacturer Narrative
The customer reported that the batteries do not last, the display gradually goes dark, and the device does not have a consistent reading.Investigation stated that the unit for the complaint is not a quality issue, the division had already been informed of the previous issues reported, and a product conversion had already taken place to rectify the problem.The complaint was not confirmed, and the cause code was dc:traced to user - data entry error.Medline stated that the division has been informed and will continue to monitor trends.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: METER,GLUCOSE,EVENCARE PROVIEW,PROF.USE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shivani gheewala ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50888642
• Report Number: 1417592-2026-50405
• Device Sequence Number: 9826263
• Product Code: NBW
• UDI-Device Identifier: 10888277409163
• UDI-Public: 10888277409163
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111456
• 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): 09/24/2026

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: MPH4540
• 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: 01/10/2023
• Initial Report FDA Received Date: 09/24/2026
• 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