URINALYSIS REAGENT STRIPS COMPLETE 10 PARAMETER TEST STRIPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-12 for URINALYSIS REAGENT STRIPS COMPLETE 10 PARAMETER TEST STRIPS manufactured by Healthywiser Llc.

Event Text Entries

[82818101] I am concerned about the efficacy of the healthywiser urinalysis reagent strips 10 parameter test. During my annual physical with my internist, a urine test detected trace blood in my urine. The following week i purchased an in-home urine test (healthywiser urinalysis reagent strips) that claims to be able to detect blood in urine. My wife, an rn, administered 4 tests, and each time the healthywiser strips did not detect blood in urine. In a subsequent follow-up with a urologist, his test showed that i indeed had trace blood in my urine as found in the original urine test by my internist. I am now undergoing various tests to pinpoint the cause of the blood in my urine. Here's my point; i am concerned that the healthywiser product is not sensitive enough to detect blood in urine as it claims. This might create a harmful situation if a consumer uses the product, feels assured that he/she does not have blood in the urine, when in fact he/she does... Which maybe cause for concern. While it may be true that the batch of product i used may be defective, i recommend that the fda check the efficacy of this product overall to be sure that it can accurately detect the 10 conditions that it claims n detect. Thank you.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5071580
• MDR Report Key: 6794373
• Date Received: 2017-08-12
• Date of Report: 2017-08-12
• Date of Event: 2017-08-04
• Date Added to Maude: 2017-08-15
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: URINALYSIS REAGENT STRIPS COMPLETE 10 PARAMETER TEST STRIPS
• Generic Name: TEST URINE LEUKOCYTE
• Product Code: LJX
• Date Received: 2017-08-12
• Lot Number: 05/22/2017
• Device Expiration Date: 2019-05-21
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HEALTHYWISER LLC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-08-12