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

Catalog Number	MPH30025SA
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device is showing false negatives.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.
Event or Problem Description
It was reported that the device is showing false negatives.

• Brand Name: MEDLINE
• Common Device Name: TEST,STREP A,DIPSTICK,25 TEST
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfiled IL 60093 2753
• Manufacturer Contact: moriah meyer ; three lakes drive; northfiled, IL 60093-2753
• MDR Report Key: 25458422
• Report Number: 1417592-2026-02339
• Device Sequence Number: 10363304
• Product Code: GTY
• UDI-Device Identifier: 10888277191884
• UDI-Public: 10888277191884
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K010582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown