MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. TRIAGE TOX DS-7

Model Number 94404

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2014

Event Type  malfunction  

Event Description

Caller reporting false positive for cocaine.The customer ran one patient sample and received positive results on all 7 drugs; amp, mamp, bar, bzo, coc, opi and trc for one cloudy patient urine sample.The customer questioned the result and noticed the sample was cloudy.She spun the sample down, repeated it within about 5 minutes of the initial positive result, and received a negative result for all drugs.The lab originally reported the positive results, but the caller corrected the reports minutes later and reported negative for all drugs after repeating the sample.The urine sample was fresh and voided into a plastic container.Urinalysis showed 30 mg/dl protein, large occult blood, large leukocyte esterase, a full field of white cells, and few bacteria.The patient was a heart patient in his 60's with a urinary tract infection.No confirmatory testing was done on the sample.There are no other questionable patient samples and the customer is not questioning this lot.Qc was run 2/24 and it produced expected results.The customer stored the sample in the fridge and agreed to send it to alere if wer would like to have the sample for investigation.The customer is aware that it has been stored in the fridge for longer than it states in the pi, but offered to send it for investigation.

Manufacturer Narrative

Data results from returned patient sample were negative for all analytes on the triage tox ds-7 panel.No positive results were observed with any devices tested.Results of further analysis of the returned patient sample with siemen's multistix showed evidence of blood in the sample.Sample abnormalities such as blood are known to cause discrepant results.This cannot be ruled out as a possible cause for the customer's observations.As of 03/20/2014 this is the only complaint against tox ds-7 lot w56062.No product deficiency was established.As there is no indication of a product deficiency, no corrective action is required at this time.

• Brand Name: TRIAGE TOX DS-7
• Type of Device: TRIAGE TOX DS-7
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3815352
• MDR Text Key: 18569804
• Report Number: 2027969-2014-00277
• 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
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 94404
• Device Lot Number: W56062RB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1