MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ICUP URINE TEST DRUG SCREEN CUP

Model Number DPG-1157-011

Device Problem False Negative Result (1225)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2021

Event Type  malfunction  

Event Description

(b)(6) 2021: customer reports fentanyl is not reading on the 15-panel expanded icup kit.No adverse outcomes reported.Although further information was requested, no additional information was provided.Customer was unresponsive.Without further information regarding the event, this event will be interpreted a false negative fentanyl result.

Manufacturer Narrative

Customer unresponsive.Investigation conclusion: the case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Retain device testing and manufacturing batch record review could not be performed as a lot number was not provided.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product.Complaints are tracked and trended on a monthly basis.Per the packet insert: is it possible that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.A negative result may not necessarily indicate drug-free urine.Negative results can still be obtained when drug is present but below the cut-off level of the test.

Manufacturer Narrative

Update to g4: 510k number was removed.It was determined the product used in this event was for forensic use only and is not fda cleared.These products are exempt from reporting requirements.

• Brand Name: ICUP URINE TEST DRUG SCREEN CUP
• Type of Device: DRUG SCREEN
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9975 summers ridge road; san diego, CA 92121 ; 8588052506
• MDR Report Key: 12888229
• MDR Text Key: 282712173
• Report Number: 2027969-2021-00111
• Device Sequence Number: 1
• Product Code: DKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DPG-1157-011
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1