MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE TOX 9 PANEL INT ICUP DOA-197-251; ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES

Model Number	DOA-197
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 products for the reported lot were tested with in-house drug free donor urine and read at 5 minutes.All devices correctly yielded negative results for all coc150 strips.No false positives were observed.Manufacturing batch record review did not uncover any abnormalities.The presence of cross-reacting substances in the test sample may result in false positive results.See section "cross-reactivity" within the performance characteristics of the package insert for a list of the substances evaluated.Substances not listed have not been evaluated.For this reason, 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 and no corrective action is required.
Event or Problem Description
The customer reported receiving a false positive cocaine result using the alere toxicology icup 9 drug panel for one donor urine specimen as compared to a negative laboratory confirmatory result (lc/ms/ms cut-off=100 ng/ml).The customer reported that only one false positive cocaine result occurred out of 100 devices used.No treatment was provided or withheld based on the false positive result.
Additional Manufacturer Narrative
Retention and returned products for the reported lot were tested with in-house drug free donor urine and read at 5 minutes.All devices correctly yielded negative results for all coc150 strips.No false positives were observed.Manufacturing batch record review did not uncover any abnormalities.The reported complaint could not be replicated with either returned or retention product.Therefore, a root cause could not be determined based on the information provided.The presence of cross-reacting substances in the test sample may result in false positive 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.

• Brand Name: ALERE TOX 9 PANEL INT ICUP DOA-197-251
• 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: 7659218
• Report Number: 2027969-2018-00082
• Device Sequence Number: 16647301
• Product Code: DIO
• UDI-Device Identifier: 10858945006062
• UDI-Public: (01)10858945006062(17)190331(10)DOA7040032
• 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,Followup
• Report Date (Section B): 07/03/2018

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: 03/31/2019
• Device Model Number: DOA-197
• Device Lot Number: DOA7040032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1