MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-07-09 for TRUGENE HIV-1 GUIDELINES RULES 12.0 & 11.0 12.0 / 11.0 06548414/06246360 manufactured by Siemens Healthcare Diagnostics.
[880521]
A customer reported a discrepancy on the interpretation of atazanavir/atazanavir+ ritonavir on trugene guidelines 12. 0. The trugene guidelines rules versions 12. 0 and 11. 0 do not provide an adequate indication of resistance levels for atazanavir (atv) in the absence of ritonavir for all mutation profiles. The indication of resistance should not be lower for unboosted atv than the indication for atv when boosted with ritonavir (atv/r) on the trugene resistance report. There has been no report of adverse health consequences as a result of the missing rule.
Patient Sequence No: 1, Text Type: D, B5
[8069025]
Trugene guidelines rules 11. 0 and 12. 0 for trugene genotyping kit and opengene dna sequencing system are developed by a consensus panel of leading experts in the field of resistance using relevant data presented at scientific symposia and published in peer reviewed journals. During the investigation of this problem, we found that a rule of unboosted atv was not added for all the mutational profiles associated with possible resistance or resistance to boosted atv (atv/r) when the mutational profiles and associated resistance to atv/r was added to guidelines 11. 0 and carried forward to guidelines 12. 0. A rule for atv in the absence of ritonavir will be added to mutational profiles associated with resistance or possible resistance to atv/r with the next guidelines rules revisions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003932969-2008-00001 |
| MDR Report Key | 1077066 |
| Report Source | 07 |
| Date Received | 2008-07-09 |
| Date of Report | 2008-06-25 |
| Date of Event | 2008-06-20 |
| Date Mfgr Received | 2008-06-25 |
| Device Manufacturer Date | 2007-05-15 |
| Date Added to Maude | 2009-05-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SONIA STEWART |
| Manufacturer Street | 725 POTTER STREET |
| Manufacturer City | BERKELEY CA 94710 |
| Manufacturer Country | US |
| Manufacturer Postal | 94710 |
| Manufacturer Phone | 3026316951 |
| Manufacturer G1 | SPARTON MEDICAL SYSTEMS |
| Manufacturer Street | 22740 LUNN ROAD |
| Manufacturer City | STRONGSVILLE OH 44149 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44149 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUGENE HIV-1 GUIDELINES RULES 12.0 & 11.0 |
| Generic Name | IN VITRO HIV DRUG RESISTANCE GENOTYPE |
| Product Code | NHS |
| Date Received | 2008-07-09 |
| Model Number | 12.0 / 11.0 |
| Catalog Number | 06548414/06246360 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-09 |