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	Bacterial Infection (1735)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "our results are not accurate using these tests" and "just this week we had 2 patients that tested negative on the medline item, while testing positive on the quickvue tests.".
Additional Manufacturer Narrative
The customer reported that results were not accurate using these tests and that 2 patients tested negative on the medline item while testing positive on the quickvue tests.A review of the complaint, manufacturing records, retained samples, and complaint history was completed; retention samples from the reported lot were tested using quality control positive standard samples, and all devices performed as expected during in-house testing.The reported false negative result could not be replicated, and the complaint could not be confirmed.Manufacturing batch records confirmed the lot met all quality control specifications, no relevant nonconformances were identified, no evidence of a systemic issue or new hazard was found, and a definitive root cause could not be determined.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: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50914694
• Report Number: 1417592-2026-51915
• Device Sequence Number: 5394569
• Product Code: GTY
• UDI-Device Identifier: 30888277191888
• UDI-Public: 30888277191888
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/25/2026

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?: 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: 05/16/2023
• Initial Report FDA Received Date: 09/28/2026
• 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