MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. 6 PANEL SCREEN TEST (DOA-264); ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES

Model Number	DOA-264
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
The customer reported receiving positive coc and amp results on every 6 panel screen test from most recent batch.The customer reported receiving three positive coc and amp results on one patient urine sample using the 6 panel screen test.The customer also reported receiving invalid results for bzo.The results were confirmed negative using another 6 panel drug test.No treatment or intervention was provided based on the results.
Additional Manufacturer Narrative
Investigation conclusion: the customer's results were not replicated in-house with retention products of the reported lot.Retention products were tested with drug-free donor urine.All coc and amp strips produced expected negative results at the read time.False positive results were not observed during the investigation.Manufacturing batch record review did not uncover any abnormalities.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• Brand Name: 6 PANEL SCREEN TEST (DOA-264)
• 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: 6790812
• Report Number: 2027969-2017-00134
• Device Sequence Number: 13701221
• Product Code: DIO
• UDI-Device Identifier: 10815845020888
• UDI-Public: (01)10815845020888(17)181031(10)DOA6120499
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K061718
• 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,Followup
• Report Date (Section B): 07/14/2017

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: DOA-264
• Device Lot Number: DOA6120499
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 08/12/2017
• Supplement Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1