MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. MULTI-DRUG 12 PANEL SCREEN (DOA-1124-081); DRUG SCREEN

Model Number	DOA-1124
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: retention devices for the reported lot number were tested with in-house drug free urine.All results were read at 5 minutes and yielded expected negative results.No false positives for any of the analytes 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.
Event or Problem Description
On (b)(6) 2018: false positive coc and mamp 1x on the multi-drug 12 panel screen no further testing or lab testing was performed.Operator explained they think this donor should be negative and that this test was a false positive.Operator did not provide justification for why they think this donor should be negative.No treatment was provided or withheld based on the false positive results.No adverse outcomes reported.No alleged delay in treatment as a result of the false positive results.

• Brand Name: MULTI-DRUG 12 PANEL SCREEN (DOA-1124-081)
• Common Device Name: DRUG SCREEN
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd; san diego CA 92121
• MDR Report Key: 8254948
• Report Number: 2027969-2019-00006
• Device Sequence Number: 16626596
• Product Code: DIO
• UDI-Device Identifier: 10858904006430
• UDI-Public: (01)10858904006430(17)200630(10)DOA8060590
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K061718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2018

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: 06/30/2020
• Device Model Number: DOA-1124
• Device Lot Number: DOA8060590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1