MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. RED -MLTI-DRG 6 PNL SCRN TST (DOA-164); ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES

Model Number	DOA-164
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; all coc, met, thc, mop, oxy, and bzo strips yielded correct negative results at read time.No false positive results were observed during in-house testing.Manufacturing batch record review did not uncover any abnormalities.The device provides only a qualitative, preliminary analytical result.A secondary analytical method must be used to obtain a confirmed result.Based on the information available, there is no indication of a product deficiency.A capa, capa (b)(4), has been opened to address the late escalation of this complaint.
Event or Problem Description
The customer reported receiving unconfirmed false positive results for all analytes using the multi-drug one step 6 drug screen test panel.The unconfirmed false positive results occurred on different random donors.The unconfirmed false positive results occurred on 23 devices out of 25 devices used.

• Brand Name: RED -MLTI-DRG 6 PNL SCRN TST (DOA-164)
• 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: 7298223
• Report Number: 2027969-2018-00025
• Device Sequence Number: 13765683
• Product Code: DIO
• UDI-Device Identifier: 10858904006317
• UDI-Public: (01)10858904006317(17)180831(10)DOA6090545
• Combination Product (Y/N): N
• 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): 02/26/2018

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-164
• Device Lot Number: DOA6090545
• 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: 01/09/2018
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1