MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. MULTI-DRUG 11 PANEL SCREEN -DOA-1114-101; DRUG SCREEN TEST

Model Number	DOA-1114
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 false positive results on the multi-drug 11 panel screen test.The specific drugs that tested positive and number of donors is unknown.It is also unknown if confirmation testing was performed.No treatment was provided or withheld.Troubleshooting was conducted with the customer.
Additional Manufacturer Narrative
An investigation was performed on retention and returned product from the reported lot number.Retention and returned 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 all analytes.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 both retention and returned product performed as expected during in-house testing.There is a possibility that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.Please note, this device 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.Complaints are tracked and trended on a monthly basis.

• Brand Name: MULTI-DRUG 11 PANEL SCREEN -DOA-1114-101
• Common Device Name: DRUG SCREEN TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 8712127
• Report Number: 2027969-2019-00115
• Device Sequence Number: 13900203
• Product Code: DIO
• UDI-Device Identifier: 10858904006416
• UDI-Public: (01)10858904006416(17)200731(10)DOA8070405
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/13/2019

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: 07/31/2020
• Device Model Number: DOA-1114
• Device Lot Number: DOA8070405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1