BIOSITE * 2303-4973

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-02 for BIOSITE * 2303-4973 manufactured by Biosite, Inc..

Event Text Entries

[507599] During lot to lot testing on the triage, i found that the negative control had a faint positive for thc. I opened a new bottle of control and repeated and got the same result. I tested a previously tested pt sample which had been reported as negative and did it and the control again. The pt was negative for thc and the negative control was positive for thc. I called biosite to report the problem and to request a different lot # of control on 5/17. I received new lot of test devices but the same lot of control. I called mfr rep back. She told me that they had a new lot but they were not ready to release it yet. I used the new bottle of control and tested 3 different lot#'s of test devices. I got positive for thc on all 3 lot #'s. Called back, she would send me a new lot # of control, lot # doao702-1 on 5/18. Rec'd control on 5/18. I tested with a different lots of test devices and still got positive on thc. Called again on 5/18 with results. She said that she was sending me same pre-tested samples to test and to call he back with results. I received the samples on 5/20, tested them and called her with the results, all my results matched their results. At that time, it was decided between us that i send her 1 bottle of each lot of control that i had tested and two devices from 3 different lot #'s of kits. These samples were sent on 5/23 to biosite inc. On 6/1, i received a call from rep saying that technical services duplicated my results in their lab. When i first called to her on 5/13, i asked her if anyone else had called with similar problems and she said no. When i spoke with her on 6/1, she said that biosite had received several complaints since i first called. Her suggestion on our last conversation was for me to use a negative pt sample for my negative control while biosite performs a major investigation. My concern is that other users of biosite triage products are unaware of the problem and that we do not know if it is the control that is the real problem or if it is the test device, or both. I have all documentation if needed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1035614
• MDR Report Key: 743628
• Date Received: 2005-06-02
• Date of Report: 2005-06-01
• Date of Event: 2005-05-13
• Date Added to Maude: 2006-08-04
• 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: MEDICAL TECHNOLOGIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: BIOSITE
• Generic Name: TRIAGE DRUGS OF ABUSE CONTROL
• Product Code: MGX
• Date Received: 2005-06-02
• Model Number: *
• Catalog Number: 2303-4973
• Lot Number: D0A0512-1
• ID Number: *
• Device Expiration Date: 2005-12-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 731426
• Manufacturer: BIOSITE, INC.
• Manufacturer Address: * SAN DIEGO CA 92121 US

Device Sequence Number: 2

• Brand Name: BIOSITE
• Generic Name: TRIAGE DRUGS OF ABUSE CONTROL
• Product Code: MGX
• Date Received: 2005-06-02
• Model Number: *
• Catalog Number: 2303-4973
• Lot Number: D0A0702-1
• ID Number: *
• Device Expiration Date: 2005-12-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 731427
• Manufacturer: BIOSITE, INC.
• Manufacturer Address: * SAN DIEGO CA 92121 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2005-06-02