MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TEST,STREP A,DIPSTICK,25 TEST

Catalog Number	MPH30025SA
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two of the 25 in box were not displaying results for patients.
Additional Manufacturer Narrative
The customer claimed that two of the 25 in box were not displaying results for patients, so they pulled the entire box thinking entire box to be defective.This is a vendor product and the investigation will be done by the vendor or vendor affiliates; vendor sent questions to the account, and medline quality has yet to receive the requested information from the customer.The reported problem could not be evaluated because the two that did not display results were disposed, there is no sample available, and no photo, video, or physical sample was provided.A formal investigation will be conducted should the customer provide medline quality with a photo, video, or a physical sample.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: TEST,STREP A,DIPSTICK,25 TEST
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joachim kamanda ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50838087
• Report Number: 1417592-2026-45863
• Device Sequence Number: 10301872
• Product Code: GTY
• UDI-Device Identifier: 30888277191888
• UDI-Public: 30888277191888
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K010582
• 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): 09/18/2026

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: MPH30025SA
• Device Lot Number: 0000640390
• Was Device Available for Evaluation?: No
• 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: 03/23/2023
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown