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: retention devices for the reported lot were tested with in-house drug free donor urine.All devices yielded expected negative results for all analytes at read time.No false positives were observed.Manufacturing batch records of the final-product, relevant product components, and quality control release data were reviewed.No relevant non-conformances, deviations, or abnormalities were found.All quality control specifications were met.Retention products performed as expected during in-house testing and could not replicate the reported complaint.This issue will be subject to tracking and trending.There is a possibility that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.Please refer to the "cross-reactivity" section within the performance characteristics portion of the package insert for a list of evaluated substances.This product provides only a qualitative, preliminary analytical result.A secondary method must be used to obtain a confirmed result.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 four occurrences of false positive coc, mamp, and opi results using the multi-drug 6 panel screen test on multiple donors.Confirmatory testing at a laboratory provided negative results.The false positive results occurred on four out of four 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: 8075630
• Report Number: 2027969-2018-00156
• Device Sequence Number: 14034670
• Product Code: DIO
• UDI-Device Identifier: 10858904006317
• UDI-Public: (01)10858904006317(17)200229(10)DOA8020330
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

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: 02/29/2020
• Device Model Number: DOA-164
• Device Lot Number: DOA8020330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1