MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU

Catalog Number	MPH11025HCG
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	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "multiple patients per day that immediately at 4mins, they begin to see a faint positive line.They will begin to keep count of how many patients per day, they are needing to run a 2nd pregnancy test.".
Additional Manufacturer Narrative
The customer reported that multiple patients per day immediately at 4mins begin to see a faint positive line and are needing to run a 2nd pregnancy test.Medline documented that this is a vendor product and the investigation will be done by the vendor or vendor affiliates; medline quality has yet to receive the requested information from the customer and follow-up attempts have been unsuccessful.The reported issue is an "unconfirmed defect - sample required to determine cause," and no root cause was identified.A formal investigation will be conducted should the customer provide medline quality with a photo, video, or a physical sample, and the division will monitor complaints through quarterly trending.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,HCG,PREGNANCY,URINE,STRIP,25 MIU
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50871212
• Report Number: 1417592-2026-49165
• Device Sequence Number: 9314655
• Product Code: JHI
• UDI-Device Identifier: 30884389191877
• UDI-Public: 30884389191877
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K993203
• 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: MPH11025HCG
• Device Lot Number: 0000674109
• 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: 08/08/2023
• Initial Report FDA Received Date: 09/23/2026
• 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