MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-13 for TRIAGE TOX DRUG SCREEN PANEL 94400EU manufactured by Alere San Diego, Inc..
[25238249]
Investigation is pending.
Patient Sequence No: 1, Text Type: N, H10
[25238250]
The customer alleged potential (b)(6) results on the triage tox drug screen panel on a patient in (b)(6). The triage tox drug screen was performed using a fresh urine sample and the following results were positive: acetaminophen (apap), benzodiazepines (bzo), tetrahydrocannabinol (thc), methamphetamines (mamp), methadone (mtd), opiates (opi). The service where the patient was hospitalized disagreed with the results. The same sample which was stored for a few hours was retested on the same strip lot and all the results were negative. There was no reported adverse patient sequela. There was no additional information provided. (note: the triage tox drug screen panel device is not available in the united states; however, this mdr filing is due to the a same or similar device being available in the united states. )
Patient Sequence No: 1, Text Type: D, B5
[33034812]
Investigation/conclusion: there were no false positive mamp, bzo, mtd, apap, opi or thc results observed from any retain devices tested with tox-ds 0. 5x calibrators or on the returned triage meterpro meter with tox ds level 1 controls. The manufacturing records for the lot were reviewed and the lot met ous release specifications. There was no sample return, therefore, sample specific interference was unable to be ruled out as a potential cause for the false positive results. There was no product deficiency established and no corrective action required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2015-00586 |
| MDR Report Key | 5002087 |
| Date Received | 2015-08-13 |
| Date of Report | 2015-07-20 |
| Date of Event | 2015-07-15 |
| Date Mfgr Received | 2015-09-25 |
| Date Added to Maude | 2015-08-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Manufacturer G1 | ALERE SAN DIEGO, INC. |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE TOX DRUG SCREEN PANEL |
| Generic Name | TOXICOLOGY DRUG SCREEN |
| Product Code | DJR |
| Date Received | 2015-08-13 |
| Returned To Mfg | 2015-08-25 |
| Model Number | 94400EU |
| Lot Number | W60203RB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-13 |