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

Catalog Number	MPH11325HCG
Medical Device Problem Codes	False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, "over the course of a couple months" the pregnancy tests are "not working", the lines are not appearing, the lines "appear either just on the very side of the cassette or halfway across" and are resulting with "false negatives".The customer reported after the incidents occur additional tests are performed.The customer reported there have been no injuries or patient impact at this time.The customer reported there was no serious injury, medical intervention, or follow-up care required related to the reported event.No additional information is available at this time.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, "over the course of a couple months" the pregnancy tests are "not working", the lines are not appearing, the lines "appear either just on the very side of the cassette or halfway across" and are resulting with "false negatives".

• Common Device Name: TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20507445
• Report Number: 1417592-2024-00910
• Device Sequence Number: 18237834
• Product Code: JHI
• UDI-Device Identifier: 20888277703565
• UDI-Public: 20888277703565
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2025
• Device Catalogue Number: MPH11325HCG
• Device Lot Number: W00131228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/22/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown