MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE ISCREEN 9 PANEL TEST (DOA-194); ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES

Model Number	DOA-194
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation pending.
Event or Problem Description
The customer reported receiving one false positive thc result and one false positive coc result on one patient using the alere iscreen 9 panel test.Confirmatory testing was conducted and produced negative results for both drugs.Although requested, no additional information was provided.
Additional Manufacturer Narrative
The customer's observation was not replicated in-house with retention products.Retention devices were tested with in-house drug free donor urine and all devices showed expected negative results for all analytes including coc and thc at read time.No false positive results were observed during in-house testing.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.
Additional Manufacturer Narrative
An investigation was performed on retention and returned products for the reported lot number.Retention and returned devices were tested with in-house drug free donor urine and all devices showed expected negative results for all analytes including coc and thc at read time.No false positive results were observed during in-house testing.Manufacturing batch record review did not uncover any abnormalities.This product provides only a qualitative preliminary analytical result.A secondary analytical method must be used to obtain a confirmed result.Gas chromatography/mass spectrometry (gc/ms) is the preferred confirmatory method.There is a possibility that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.A positive result might be obtained from certain foods or food supplements.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• Brand Name: ALERE ISCREEN 9 PANEL TEST (DOA-194)
• 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: 6989010
• Report Number: 2027969-2017-00159
• Device Sequence Number: 1677082
• Product Code: DIO
• UDI-Device Identifier: 10858945006529
• UDI-Public: (01)10858945006529(17)190131(10)DOA7020215
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2017

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: No Information
• Device Expiration Date: 01/31/2019
• Device Model Number: DOA-194
• Device Lot Number: DOA7020215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 12/07/2017; 08/02/2018
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 12/12/2017; 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1