MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. TRIAGE TOX DRUG SCREEN PANEL; DOA DRUG SCREEN TEST

Model Number 94400

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Customer questioning 3 runs of tox panel on triage meter, each time run, different analytes tested positive.Customer stated a urine sample from one patient was tested 3 times on 2 triage meters and both meters gave the same results each time, but the results themselves were different for each run.The 1st run- 7 analytes tested positive.The 2nd run (time not provided)- just thc positive.The 3rd run (time not provided)- just thc and bar positive.Patient was visiting the hospital for a potential medication overdose.Customer was unable to recall patient data due to no patient identifier given on initial report.Caller unable to gather information on which specific analytes were positive on the first tests run.At the time reported, no confirmatory testing was performed.Although requested no confirmatory results were reported.No reported adverse patient sequela.No further information provided.

Manufacturer Narrative

Investigation/conclusion: received 1 false negative bar result when testing retain lot w61921 with positive tox calibrator 1.5x.Review of the device scan showed an abnormally thin and long peak at the bar position, this is the root cause of the false negative result.No issues observed with tox calibrator 0.5x testing.No sample was returned to product support, further investigation cannot be pursued.Reviewed the batch record for lot w61921.Lot met all final release specifications.

• Brand Name: TRIAGE TOX DRUG SCREEN PANEL
• Type of Device: DOA DRUG SCREEN TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6031967
• MDR Text Key: 57693174
• Report Number: 2027969-2016-00650
• Device Sequence Number: 1
• Product Code: DJR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 94400
• Device Lot Number: W61921B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TRIAGE METERPRO DOMESTIC KIT SERIAL # UNKNOWN