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

Catalog Number	MPH4540
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1 out of the 6 glucose meters ordered (item#: mph4540) were defective and incorrectly reading glucose levels.She advised when level 2 test strips are entered, the reading should be between 74-99 and this item kept having a reading of 71.
Additional Manufacturer Narrative
The customer reported that 1 out of the 6 glucose meters ordered were defective and incorrectly reading glucose levels, and when level 2 test strips are entered, the reading should be between 74-99 and this item kept having a reading of 71.Medline received 1 evencare proview blood glucose meter in like-new condition with working batteries; test strips and solution used by the account were not sent for investigation, and the sample was tested according to the instructions for use using control evencare proview test strips and evencare proview control solutions.After testing was conducted, the meter displayed glucose readings within both control solution ranges, 71 mg/dl for level 2 and 225 mg/dl for level 3, and medline experienced no issues during testing; the meter turned on and off and displayed readings within control solution range.The complaint was not confirmed with the received sample, and based on review of the complaint investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications; the sample worked as intended.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: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50941911
• Report Number: 1417592-2026-53980
• Device Sequence Number: 18828706
• Product Code: NBW
• UDI-Device Identifier: 10888277409163
• UDI-Public: 10888277409163
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/28/2026

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
• Date Returned to Manufacturer: 01/15/2024
• 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: 01/02/2024
• Initial Report FDA Received Date: 09/30/2026
• 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 Sex: Unknown