MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2014-07-28 for TRIAGE 8, 25 TEST 90008 manufactured by Alere San Diego, Inc..
[15118907]
Caller alleged discrepant cocaine results. Results as follows: patient presented to the emergency department on (b)(6) 2014 after falling off her bike. The patients urine was tested at 12:30 am, using triage 8 (lot #332098). Test results showed positive for cocaine with all other alytes showing negative. The physician questioned the positive cocaine result. The lab ran the urine samples using a different lot number (#333188) and all analytes showed negative. The day shift at the lab repeated the urine test using both triage 8 lot numbers and replicated the night shift's results; ln 332098=positive coc, whereas ln 333188=negative coc. The urine sample was refrigerated for a few days before being sent out for confirmatory testing; gc/ms result=242 ng/ml. The patient stated she used cocaine on (b)(6) 2014. The patient also stated that her friend gave her something for pain prior to presenting at the emergency department on (b)(6) 2014. Qc on both lot numbers was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[15395911]
Procode: dio, dis, djg, djr, jxm, lcm, lpg. Investigation: testing results showed that all devices tested with dfu (drug free urine) donor samples were negative for all analytes as expected. No patient sample was returned for investigation. Unable to rule out sample specific interference as a potential cause for discrepant results. A review of manufacturing batch records for doa lot 332098 showed that no discrepant results were observed during final release testing. No relevant non-conformances were issued for this lot. As of (b)(4) 2014, there are only (b)(4) complaints against doa lot 332098. No product deficiency was established.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2014-00707 |
| MDR Report Key | 4016835 |
| Report Source | 00,05 |
| Date Received | 2014-07-28 |
| Date of Report | 2014-07-10 |
| Date of Event | 2014-07-09 |
| Date Mfgr Received | 2014-07-10 |
| Date Added to Maude | 2014-08-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE 8, 25 TEST |
| Generic Name | DRUGS OF ABUSE TEST |
| Product Code | DKZ |
| Date Received | 2014-07-28 |
| Model Number | 90008 |
| Lot Number | 332098 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-07-28 |