FDA Adverse Event Malfunction Summary report: N

CHOLESTEROL BIO METER BY Q.STEPS

MDR report key: 4128677 · Received September 24, 2014

Report

Report Number
MW5038380
Event Type
Malfunction
Date Received
September 24, 2014
Date of Event
May 19, 2014
Report Date
September 24, 2014
Manufacturer
BIOMEDIX, INC. USA
Product Code
CGA
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

(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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
595656 CHOLESTEROL BIO METER BY Q.STEPS NONE CGA BIOMEDIX, INC. USA
595657 CHOLESTEROL BIO METER BY Q.STEPS NONE CGA BIOMEDIX, INC. USA
595820 CHOLESTEROL BIO METER BY Q.STEPS NONE CGA BIOMEDIX, INC. USA

Patients

Seq Age Sex Outcome Treatment
1 61 YR CHOLESTEROL METER| GLUCOSE METER