MAUDE Adverse Event Report: BIOMEDIX, INC. USA CHOLESTEROL BIO METER BY Q.STEPS; NONE

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2014

Event Type  malfunction  

Event Description

(b)(6) 2014 - lab test at (b)(6) shows cholesterol was 224 - q.Steps bio-meter showed 150; (b)(6) 2014 - chol.Screening by summit health at (b)(6), showed cholesterol 176 - q.Steps bio-meter showed "lo"; contacted the company after much conversation, they sent me a used meter.(b)(6) 2014 - lab test at (b)(6) shows chol was 219 - q.Steps bio-meter showed 157; (b)(6) 2014 chol.Screening by summit health at (b)(6) showed cholesterol 234 - q.Steps bio-meter showed 175.I tried contacting the company numerous times (b)(4).On (b)(6) 2014, tried three times that day - received - your party is not answering - please try your call again later.We are sorry but your call will be disconnected - (b)(4).I have tried many times since only to get a fast busy signal.I also contacted the company where i bought the testing strips - (b)(6) 2014, 11:50 am, (b)(4) (spoke to (b)(4)).He had no information on the contact information for the bio-meter.They still sell the cholesterol strips.It appears neither of the machines, the new or used bio-meter, are accurate.I even sent an email to my contact at biomedix, inc.Usa.(b)(6) 2014 - sent an email to (b)(4).As of (b)(6) 2014, i have had no response.I paid (b)(4) for the meter and (b)(4) for the testing strips at (b)(4).I also purchased additional strips from (b)(4) products, 191 ambroglo dr.(b)(6) in the amount of $(b)(4) for 9 strips total.

• Brand Name: CHOLESTEROL BIO METER BY Q.STEPS
• Type of Device: NONE
• Manufacturer (Section D): BIOMEDIX, INC. USA; fremont CA 94538
• MDR Report Key: 4128677
• MDR Text Key: 16776454
• Report Number: MW5038380
• Device Sequence Number: 2
• Product Code: CGA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/24/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Treatment: CHOLESTEROL METER; GLUCOSE METER
• Patient Age: 61 YR
• Patient Weight: 68