MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. MULTI-DRUG 10 PANEL SCREEN -DOA-1104-751; DRUG SCREEN

Model Number	DOA-1104
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 multi-drug 10 panel screen test.The patients were not on any medications.Confirmatory lab testing was performed and provided negative results for coc.No treatment provided or withheld based on result.No further information was provided.
Additional Manufacturer Narrative
An investigation was performed on retention product from the reported lot number.Retention devices were tested with in-house drug-free donor urine samples.Results were read at 5 minutes and all devices yielded expected negative results for coc.No false positive results were observed during in-house testing.Manufacturing batch record review did not uncover any abnormalities and found that the lot met quality control specifications.A root cause could not be determined from the available information as retention product performed as expected.However, case details indicate that the confirmatory testing performed was done at a cut-off of 300 ng/ml.As the cut-off for coc on this device is 150 ng/ml, it is possible for a donor to correctly test positive on this device and negative on the confirmatory testing.For this reason, confirmatory testing should be performed at the same cut-off as the device.Complaints are tracked and trended on a monthly basis.

• Brand Name: MULTI-DRUG 10 PANEL SCREEN -DOA-1104-751
• Common Device Name: DRUG SCREEN
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 8580235
• Report Number: 2027969-2019-00079
• Device Sequence Number: 16603361
• Product Code: DIO
• UDI-Device Identifier: 10858904006409
• UDI-Public: (01)10858904006409(17)200930(10)DOA8090450
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 05/22/2019

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: DOA-1104
• Device Lot Number: DOA8090450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/05/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1