FDA Adverse Event Malfunction Summary report: N

BIOSAFE

MDR report key: 1084859 · Received July 30, 2008

Report

Report Number
MW5007841
Event Type
Malfunction
Date Received
July 30, 2008
Date of Event
July 11, 2008
Report Date
July 30, 2008
Manufacturer
BIOSAFE MEDICAL TECHNOLOGIES, INC.
Product Code
NFX
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

PURCHASED CHOLESTEROL PANEL TEST VIA AMAZON. COM FROM BIOSAFE. DID BLOOD SAMPLE ON EVENING OF 2008. SENT ON MORNING OF THE NEXT DAY. PER INSTRUCTIONS FROM THE BIOSAFE WEBSITE, IT TYPICALLY TAKES 5 DAYS TO ARRIVE AT THEIR LABORATORY TO PROCESS. HOWEVER, IT CAN TAKE UP TO TWO WEEKS. I WAITED OVER TWO WEEKS AND CONTINUED TO CHECK THE ONLINE SPECIMEN TRACKING SYSTEM FROM THEIR WEBSITE DAILY. THE NUMBER ON MY TEST AUTHORIZATION FORM DOES NOT APPEAR ON THEIR WEBSITE. I CALLED THE 888 NUMBER LISTED ON THE RESPONSE WEB PAGE AND IT DOES NOT CONNECT. I THEN FOUND A NUMBER FOR CUSTOMER SERVICE WHO THEN GAVE ME THE LAB CUSTOMER SERVICE NUMBER. THE RESPONSE MESSAGE IS THE LAB CURRENTLY CLOSED AND TO CALL BACK DURING WORKING HOURS OF 9 TO 5, M-F. I CALLED SEVERAL TIMES BETWEEN THESE HOURS DURING THE PAST THREE DAYS AND RECEIVE THE SAME MESSAGE. I AM VERY CONCERNED AT THIS POINT AND CALLED THE REGULAR CUSTOMER SERVICE NUMBER. THIS TIME A LADY RESPONDED THAT THE LAB IS CLOSED. HOW DO YOU CLOSE A LAB THAT MUST PROCESS BLOOD SAMPLES ON A TIMELY BASIS IN ORDER TO OBTAIN ACCURATE RESULTS?? SHE WAS VERY VAGUE, SO I ASKED HER IF THE COMPANY WAS GOING OUT OF BUSINESS OR HAD AN ISSUE WITH PROCESSING THE BLOOD SAMPLES FOR THEIR DIFFERENT TYPES OF TESTS. SOMETHING IS NOT RIGHT HERE!! I AM CONTACTING YOU BECAUSE THE PRODUCTS THEY OFFERED ARE SUPPOSEDLY FDA APPROVED. WHAT CAN I DO AT THIS POINT??? DIAGNOSIS OR REASON FOR USE; CHOLESTEROL LEVEL TEST.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BIOSAFE CHOLESTEROL PANEL NFX BIOSAFE MEDICAL TECHNOLOGIES, INC. BF01L

Patients

Seq Age Sex Outcome Treatment
1 45 YR