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

Catalog Number	MPH4540
Medical Device Problem Codes	Computer Software Problem (1112); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "err4 before even counting down and it definitely has enough blood and testing solution." "it throws an error at four before it even starts counting down.".
Additional Manufacturer Narrative
The customer reported receiving a medline evencare proview glucose meter that was giving an error message during use; there was no reported death or serious injury associated with this event.Medline received the meter in used condition with working batteries and tested it using control evencare proview test strips and control solutions; the meter turned on and the blood icon appeared, but an "er4" message was displayed during testing for a total of three times, and visual inspection confirmed the presence of an adequate amount of control solution.The complaint was confirmed by medline; the vendor reported that, through internal investigation including dhr review and inspection records review, no abnormalities were found and the complaint could not be confirmed.No root cause was identified in the provided investigation, and medline concluded that the meter did not work as intended; no trends were identified for the specified material number and corresponding defect type.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: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50870182
• Report Number: 1417592-2026-49020
• Device Sequence Number: 9224079
• Product Code: CGA
• UDI-Device Identifier: 10888277409163
• UDI-Public: 10888277409163
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/23/2026

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: 05/06/2025
• 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: 04/24/2025
• Initial Report FDA Received Date: 09/23/2026
• 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