MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; 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	06/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6), ".The patient's urine sample was tested 3 times with this test strip.The first test was positive (2 lines present) and the following two tests were negative (one line present).Due to facility policy, the patient's routine colonoscopy was cancelled.There was no serious injury and the patient is stable.The patient had regular menstrual cycles and followed up subsequently with her pcp and had a negative serum hcg test.".It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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 facility on (b)(6), "the patient's urine sample was tested 3 times with this test strip.The first test was positive (2 lines present) and the following two tests were negative (one line present).".

• Common Device Name: TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20291468
• Report Number: 1417592-2024-00861
• Device Sequence Number: 8127422
• Product Code: JHI
• UDI-Device Identifier: 30884389191877
• UDI-Public: 30884389191877
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

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
• Device Catalogue Number: MPH11025HCG
• Device Lot Number: 718644
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/24/2024
• 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 Age: 19 YR
• Patient Sex: Female
• Patient Weight: 50 KG