BIOSAFE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-30 for BIOSAFE manufactured by Biosafe Medical Technologies, Inc..

Event Text Entries

[19681597] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5007841
MDR Report Key1084859
Date Received2008-07-30
Date of Report2008-07-30
Date of Event2008-07-11
Date Added to Maude2008-08-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBIOSAFE
Generic NameCHOLESTEROL PANEL
Product CodeNFX
Date Received2008-07-30
Lot NumberBF01L
ID Number90050300
OperatorLAY USER/PATIENT
Device AvailabilityN
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1071297
ManufacturerBIOSAFE MEDICAL TECHNOLOGIES, INC.
Manufacturer AddressLAKE FOREST IL 60045 US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-07-30

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