MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-27 for TRUEGENE HIV-1 GENOTYPING KIT 10336823, 10336826 manufactured by Siemens Medical Diagnostics.
[18803523]
This product is used to evaluate whether a specific codon mutation exits and whether the codon indicates drug resistance. In this case, the reporting lab correctly questioned the results. For medical device reporting purposes, this event is considered closed.
Patient Sequence No: 1, Text Type: N, H10
[18849894]
Results were obtained for the trugene hiv-1 genotyping kit that could result in a misinterpretation of the resistance profile. No results have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003932969-2012-00002 |
| MDR Report Key | 2556460 |
| Report Source | 05 |
| Date Received | 2012-04-27 |
| Date of Report | 2012-03-29 |
| Date of Event | 2012-03-27 |
| Device Manufacturer Date | 2012-02-28 |
| Date Added to Maude | 2012-09-14 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUEGENE HIV-1 GENOTYPING KIT |
| Generic Name | TRUEGENE HIV-1 GENOTYPING KIT |
| Product Code | NHS |
| Date Received | 2012-04-27 |
| Model Number | NA |
| Catalog Number | 10336823, 10336826 |
| Lot Number | U080A1, U080A2 |
| ID Number | NA |
| Device Expiration Date | 2013-01-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVE. TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-27 |