MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. COC 150 COCAINE SINGLE TEST PANEL; DRUG SCREEN

Model Number	DCO-U114
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
It was reported that on an unspecified date, the customer received multiple false positive results for coc on the coc 150 cocaine single test panel.The exact number of false positive results received is unknown.No confirmatory lab testing was done.The tests were being used for probation/ parole court clients.No treatment was provided or withheld based on result.
Additional Manufacturer Narrative
Retention products for the reported lot number were tested with in-house drug free donor urine.All test devices produced expected negative results for coc at the 5-minute read time.No false positive results 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.The reported complaint for false positive coc results was not replicated as retention products performed as expected.A root cause could not be determined based on the information provided.This 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.

• Brand Name: COC 150 COCAINE SINGLE TEST PANEL
• Common Device Name: DRUG SCREEN
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 8580239
• Report Number: 2027969-2019-00080
• Device Sequence Number: 1537003
• Product Code: DIO
• UDI-Device Identifier: 10858904006515
• UDI-Public: (01)10858904006515(17)200630(10)COC8060038
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: DCO-U114
• Device Lot Number: COC8060038
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1