MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; STRIPS,URINE,REAGENT,10SG,100 STRIPS/BT

Catalog Number	MPHUA10SG
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, "on (b)(6) 2025, 67 y/o female into the office with c/o of urinary tract infection signs and symptoms.Patient denied any fever but was c/o pain upon urination, blood in urine and strong odor to her urine.A urine dip was completed using the urine reagent 10sg 100 strips/bt, with the ref# mphua10sg, lot # 98124030001, with expiration date of 04/10/2026.The dip showed positive for blood, protein and ketones.All other results on strip were negative.Our provider sent the urine sample to the lab with an order for ua with cns microscopic.It resulted with wbc esterase +1, occult blood +1, wbc 11- 30, epithelial cells >10/hpf, crystals present, bacteria-many and yeast present, with a result of escherichia coli.Patient was started on macrobid 100 mg po bid for 5 days, and educated on uti prevention.Patient is now stable".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) 2025, 67 y/o female into the office with c/o of urinary tract infection signs and symptoms.Patient denied any fever but was c/o pain upon urination, blood in urine and strong odor to her urine.A urine dip was completed using the urine reagent 10sg 100 strips/bt, with the ref# mphua10sg, lot # 98124030001, with expiration date of 04/10/2026.The dip showed positive for blood, protein and ketones.All other results on strip were negative.

• Common Device Name: STRIPS,URINE,REAGENT,10SG,100 STRIPS/BT
• 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: 21510398
• Report Number: 1417592-2025-00116
• Device Sequence Number: 4449404
• Product Code: JIR
• UDI-Device Identifier: 10884389181911
• UDI-Public: 10884389181911
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 03/03/2025

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 Expiration Date: 04/10/2026
• Device Catalogue Number: MPHUA10SG
• Device Lot Number: 98124030001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 03/03/2025
• 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: 67 YR
• Patient Sex: Female