MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-27 for TRIAGE TOX DS-7 94404 manufactured by Alere San Diego, Inc..
[18569804]
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.
Patient Sequence No: 1, Text Type: D, B5
[18939120]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2014-00277 |
| MDR Report Key | 3815352 |
| Report Source | 05 |
| Date Received | 2014-03-27 |
| Date of Report | 2014-03-03 |
| Date of Event | 2014-02-27 |
| Date Mfgr Received | 2014-03-03 |
| Date Added to Maude | 2014-06-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | YA KING |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE TOX DS-7 |
| Generic Name | TRIAGE TOX DS-7 |
| Product Code | DJR |
| Date Received | 2014-03-27 |
| Model Number | 94404 |
| Lot Number | W56062RB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-27 |