MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. MULTI-DRUG 5 PANEL SCREEN TEST; ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES

Model Number	DOA-654
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 conclusion: 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 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.
Event or Problem Description
The customer reported 40 occurrences of false positive results on all drugs using the multi-drug 5 panel screen on random donors starting in (b)(6) of 2017.Testing at an external laboratory provided negative results.The customer reported that out of 325 devices used, 40 produced false positive results.

• Brand Name: MULTI-DRUG 5 PANEL SCREEN TEST
• 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: 6822697
• Report Number: 2027969-2017-00136
• Device Sequence Number: 13810736
• Product Code: DIO
• UDI-Device Identifier: 10858904006249
• UDI-Public: (01)10858904006249(17)180831(10)DOA6090505
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 08/08/2017

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-654
• Device Lot Number: DOA6090505
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1