MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. COC THC OPI AMP MAMP PCP BZO BAR MTD MDM; ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES

Model Number	DOA-21107
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
The customer reported receiving positive amp, coc, and thc results on two donors using two multi-drug 10 panel cups.The donors denied having drugs in their system.Testing was performed on an alternate lot of multi-drug 10 panel cups and produced negative results.The positive results occurred on 2 devices out of 4 devices used.No laboratory confirmation testing was performed and no additional information available.
Additional Manufacturer Narrative
Investigation conclusion: retention product for the reported lot number was tested with in-house, drug-free donor urine.All devices produced expected negative results for all analytes, including amp, coc, and thc.No false positive results were observed during testing.Review of manufacturing batch records did not uncover any abnormalities.The reported complaint of false positives was not replicated as retention product performed as expected.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.
Additional Manufacturer Narrative
Investigation conclusion: retention and returned products for the reported lot number were tested with in-house, drug-free donor urine.All devices produced expected negative results for all analytes, including amp, coc, and thc.No false positive results were observed during testing.Review of manufacturing batch records did not uncover any abnormalities.The reported complaint of false positives was not replicated as retention and returned product performed as expected.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.

• Brand Name: COC THC OPI AMP MAMP PCP BZO BAR MTD MDM
• 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: 7974963
• Report Number: 2027969-2018-00138
• Device Sequence Number: 16579177
• Product Code: DIO
• UDI-Device Identifier: 10815845020765
• UDI-Public: (01)10815845020765(17)191031(10)DOA7100506
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2018

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: 10/31/2019
• Device Model Number: DOA-21107
• Device Lot Number: DOA7100507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 11/14/2018; 12/20/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 12/14/2018; 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1