MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-03 for TRUGENE HIV-1 GENOTYPING KIT 10336823, 10336826 manufactured by Siemens Healthcare Diagnostics.
[2750789]
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
[9966421]
This product is used to evaluate whether a specific codon mutation exists 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
| Report Number | 3003932969-2012-00003 |
| MDR Report Key | 2565908 |
| Report Source | 05 |
| Date Received | 2012-05-03 |
| Date of Report | 2012-04-20 |
| Date of Event | 2012-04-16 |
| Date Mfgr Received | 2012-04-20 |
| Device Manufacturer Date | 2012-02-28 |
| Date Added to Maude | 2012-09-18 |
| 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 | RICHARD MORGAN |
| Manufacturer Street | 725 POTTER ST. |
| Manufacturer City | BERKELEY CA 94710 |
| Manufacturer Country | US |
| Manufacturer Postal | 94710 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | 511 BENEDICT AVE. |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 10591 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUGENE HIV-1 GENOTYPING KIT |
| Generic Name | TRUGENE HIV-1 GENOTYPING KIT |
| Product Code | NHS |
| Date Received | 2012-05-03 |
| 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 HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVE. TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-03 |