MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. TRIAGE TOX DRUG SCREEN PANEL; ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES

Model Number	94400EU
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the customer's complaint of false negative coc was not replicated with in-house testing of retains of lot w62351rb.Manufacturing batch records for lot w62351rb were reviewed and found that the lot met release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.This event is being reported as part number 94400eu is same/similar to k060791.
Event or Problem Description
The customer reported the following event occurring on one patient: on (b)(6) 2017, the patient's urine sample was tested with the triage tox drug screen panel and produced a negative cocaine result.The triage tox drug screen panel cocaine threshold concentration is 300 ng/ml.An immunochromatography inlab cocaine test was performed and produced a positive result.The cut-off point for the inlab cocaine test is 300 ng/ml.The sample was sent to (b)(6) laboratory (kims methodology) and on (b)(6) 2017 a positive result cocaine was received.The cocaine decision level for the (b)(6) laboratory test is 150 ng/ml.Although requested, no additional information is available.

• Brand Name: TRIAGE TOX DRUG SCREEN PANEL
• Common Device Name: ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 6553177
• Report Number: 2027969-2017-00084
• Device Sequence Number: 606332
• Product Code: DIO
• UDI-Device Identifier: 00899722002757
• UDI-Public: (01)00899722002757(10)W62351RB(17)170531(11)161117
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K060791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 94400EU
• Device Lot Number: W62351RB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 05/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRIAGE METERPRO, PN 55071, SERIAL (B)(4)