MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-10-22 for MEDTOXSCAN 833062 manufactured by Medtox Diagnostics, Inc..
[704662]
Patient was admitted through er exhibiting slurred speech. Urine drug screen was ordered. Test methodology used was the medtox profile iii er 9 panel test cartridge, lot number 107. Medtoxscan cartridge reader device was used. The reader read thc, benzodiazepine, methadone, and tricyclic antidepressants as positive. Patient was admitted with drug abuse as one of her diagnoses. Patient denied using drugs. Negative control was performed and read thc and benzodiazepines as positive. Repeat pt drug screen was only positive for benzodiazepines, which she was taking. Patient later became much more ill and was transferred to an icu bed at another facility for sepsis. Concern is that because this device malfunctioned, pt symptoms were partially attributed to drug abuse. Patient misdiagnosis occurred due to device failure. Dates of use: 2007. Diagnosis or reason for use: patient symptoms, history of prescription drug abuse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004224 |
| MDR Report Key | 935956 |
| Date Received | 2007-10-22 |
| Date of Report | 2007-10-22 |
| Date of Event | 2007-10-20 |
| Date Added to Maude | 2007-11-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTOXSCAN |
| Generic Name | DRUG SCREEN READER |
| Product Code | MVO |
| Date Received | 2007-10-22 |
| Model Number | 833062 |
| Lot Number | 602120 |
| ID Number | REV: D, A8 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 911753 |
| Manufacturer | MEDTOX DIAGNOSTICS, INC. |
| Manufacturer Address | 1238 ANTHONY ROAD BURLINGTON NC 27215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2007-10-22 |