MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. 10 PNL INTEGRATED CUP W/ADULT; DRUG SCREEN TEST

Model Number	DUE-1107
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
Retention devices for the reported lot were tested with in-house drug-free donor urine.All devices were read at 5 minutes and yielded expected negative results.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.Complaints are tracked and trended on a monthly basis.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.Per the package insert, there is a possibility that 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.A positive result might be obtained from certain foods or food supplements.
Event or Problem Description
It was reported that on an unspecified date, the patient was tested on the 10 pnl integrated cup device and received a false positive cocaine (coc) result.Confirmation lab testing was performed.No further information would be provided.

• Brand Name: 10 PNL INTEGRATED CUP W/ADULT
• Common Device Name: DRUG SCREEN TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 8819020
• Report Number: 2027969-2019-00173
• Device Sequence Number: 321315
• Product Code: DIO
• UDI-Device Identifier: 10858945006284
• UDI-Public: (01)10858945006284(17)200930(10)DOA8100040
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2019

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: 09/30/2020
• Device Model Number: DUE-1107
• Device Lot Number: DOA8100040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1