MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; METER, GLUCOSE, EVENCARE G2

Catalog Number	MPH1540
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "3 each mph1540 glucometers that are testing out of range" and that "they have tried several different solutions/test strips and the results are still the same.".
Additional Manufacturer Narrative
The customer reported that 3 glucometers were testing out of range and stated that they have tried several different solutions/test strips and the results are still the same; after troubleshooting, they were still having issues with 3 meters when using the control solution.A sample and/or photo was requested from the customer, as well as lot information; however, the customer was unable to provide a sample, photo, and lot information, and the customer was contacted and requested to provide additional information.Based on the results of the investigation and the lack of lot number information, medline was unable to confirm the complaint issue or that the product failed to meet specifications; the cause was unconfirmed, with a sample required to determine cause.A review of the complaint information as well as the results of the investigation indicated no need for further action, and if additional information becomes available this complaint will be reopened, updated, and investigated as necessary.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 G2
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931636
• Report Number: 1417592-2026-52932
• Device Sequence Number: 15827254
• Product Code: NBW
• UDI-Device Identifier: 00884389102551
• UDI-Public: 00884389102551
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K102037
• 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): 09/29/2026

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: MPH1540
• 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: 01/09/2025
• Initial Report FDA Received Date: 09/29/2026
• 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