MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. COC THC MOP AMP MAMP BZO BAR MTD MDMA OX; ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES

Model Number	DOA-1127
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation pending.
Event or Problem Description
The customer reported 12 instances of false positive coc, opi, and thc results and 2 instances of conflicting opi results between august 2016 and april 2018.The customer was unable to provide the frequency of the false positive results for each specified analyte.Confirmatory testing was performed at (b)(6) toxicology and (b)(6) detention center for all 12 instances of false positive results.Confirmatory testing provided negative results each time for coc, opi, and thc.
Additional Manufacturer Narrative
Investigation conclusion: an investigation was performed on retention and returned products for the reported lot number.Retention and return products were tested with in-house drug-free donor urine.Results were read at 5 minutes and all devices correctly yielded negative results for all analytes.No migration issues or false positive results were observed.Manufacturing batch record review did not uncover any abnormalities.The 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: COC THC MOP AMP MAMP BZO BAR MTD MDMA OX
• 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: 7539235
• Report Number: 2027969-2018-00059
• Device Sequence Number: 19190774
• Product Code: DIO
• UDI-Device Identifier: 10815845020789
• UDI-Public: (01)10815845020789(17)180831(10)DOA6090031
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 05/23/2018

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 Expiration Date: 08/31/2018
• Device Model Number: DOA-1127
• Device Lot Number: DOA6090031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1