DRI TRICYCLICS SERUM TOX ASSAY *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-01 for DRI TRICYCLICS SERUM TOX ASSAY * manufactured by Microgenics, Inc.

Event Text Entries

[2921180] Recently a patient's urine drug screen came back positive and the patient insisted that she was not taking tricyclics. A recollected urine came back negative for tricyclics. An investigation followed involving recalibrating using the current calibrator in use. The calibration was used. We recalibrated using new calibrator and new reagent and new controls. This time the calibration was acceptable. Upon review of the records, we saw that the previous calibrations on 10/9, (600), 10/12 (680), 10/15 (600), 10/21 (600) were possibly too low, although the control values were acceptable. We keep urine specimens for seven days and were able to retrieve the drug screen specimens from 10/15 through 10/21 for repeat testing. Of those twenty specimens, eleven specimens were found to have been reported as falsely positive for urine tricyclics, and nine specimens were originally reported as falsely positive for urine tricyclics, and remained positive upon repeat testing. Eleven specimens were unable to be rerun due to having been discarded (older than 7 days). Corrected reports were sent to the ordering physicians for the affected patients.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	2829546
MDR Report Key	2829546
Date Received	2012-11-01
Date of Report	2012-11-01
Date of Event	2012-10-15
Report Date	2012-11-01
Date Reported to FDA	2012-11-01
Date Added to Maude	2012-11-13
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	RISK MANAGER
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	DRI TRICYCLICS SERUM TOX ASSAY
Generic Name	ASSAY
Product Code	DKB
Date Received	2012-11-01
Model Number	*
Catalog Number	*
Lot Number	59729835
ID Number	*
Operator	OTHER
Device Availability	Y
Device Sequence No	1
Device Event Key	0
Manufacturer	MICROGENICS, INC
Manufacturer Address	46360 FREMONT BLVD FREEMONT CA 94538 US 94538

Device Sequence Number: 2

Brand Name	DRI SERUM TOX NEGATIVE CALIBRATOR
Generic Name	CALIBRATOR
Product Code	DKB
Date Received	2012-11-01
Model Number	*
Catalog Number	*
Lot Number	59682419
ID Number	*
Device Availability	N
Device Sequence No	2
Device Event Key	0
Manufacturer	MICROGENICS, INC.
Manufacturer Address	46360 FREMONT BLVD FREEMONT CA 94538 US 94538

Device Sequence Number: 3

Brand Name	DRI SERUM TOX
Generic Name	CALIBRATOR
Product Code	DKB
Date Received	2012-11-01
Model Number	*
Catalog Number	*
Lot Number	5975728
ID Number	*
Device Availability	N
Device Sequence No	3
Device Event Key	0
Manufacturer	MICROGENICS, INC
Manufacturer Address	46360 FREMONT BLVD FREEMONT CA 94538 US 94538

Device Sequence Number: 4

Brand Name	SERUM TOX CALIBRATOR 4
Generic Name	CALIBRATOR
Product Code	DKB
Date Received	2012-11-01
Model Number	*
Catalog Number	*
Lot Number	59776879
ID Number	*
Device Availability	N
Device Sequence No	4
Device Event Key	0
Manufacturer	MICROGENICS, INC
Manufacturer Address	46360 FREMONT BLVD FREEMONT CA 94538 US 94538

Device Sequence Number: 5

Brand Name	UNICEL DXC
Generic Name	ANALYZER, CHEMISTRY
Product Code	JJE
Date Received	2012-11-01
Model Number	680 OR 600
Catalog Number	*
Lot Number	*
ID Number	*
Device Availability	Y
Device Sequence No	5
Device Event Key	0
Manufacturer	BECKMAN COULTER, INC
Manufacturer Address	250 SOUTH KRAEMER BLVD BREA CA 92821 US 92821

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-11-01