MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-12-23 for AMPLICOR HIV-1 MONITOR TEST, VERSION 1.5 21117750 123 manufactured by Roche Molecular Systems, Inc..
[407650]
The customer tested the same pediatric specimen with the amplicor hiv-1 monitor test, v 1. 5 using both the ultrasensitive and standard test methodologies. The standard method has a stated assay range of 400 to 750,000 c/ml of hiv-1 rna. The ultrasensitive method has a stated assay range of 50 to 100,000 c/ml of hiv-1 rna. With the standard method, a titer of 467,434 c/ml was generated with amplicor hiv-1 monitor test, v 1. 5 lot g05626. With the ultrasensitive method, titers of 8618 c/ml and 20364 c/ml were generated with lots g05626 and g06583 respectively. Using the standard method, vqa proficiency samples of 1,500, 15,000 and 150,000 c/ml generated results within established ranges with lot g05626. Using the ultrasensitive method and lot g05626, these same samples generated results within established ranges for the low and mid range vqa samples. The high vqa sample generated titers 45,000, 87,000 and 69,000 c/ml using the ultrasensitive method. No erroneous patient results were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2005-00027 |
| MDR Report Key | 657160 |
| Report Source | 05 |
| Date Received | 2005-12-23 |
| Date of Report | 2005-12-07 |
| Date Mfgr Received | 2005-12-07 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2005-12-30 |
| 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 | 0 |
| Manufacturer Contact | ROBERT PIGOZZI |
| Manufacturer Street | 1080 US HIGHWAY 202 SOUTH |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9257308272 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLICOR HIV-1 MONITOR TEST, VERSION 1.5 |
| Generic Name | IN VITRO DIAGNOSTIC DEVICE, NAT |
| Product Code | MTL |
| Date Received | 2005-12-23 |
| Model Number | NA |
| Catalog Number | 21117750 123 |
| Lot Number | G05626 |
| ID Number | * |
| Device Expiration Date | 2006-08-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 646648 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | * BRANCHBURG NJ 08876 US |
| Baseline Brand Name | AMPLICOR HIV-1 MONITOR TEST, VERSION 1.5 |
| Baseline Generic Name | IN VITRO DIAGNOSTIC DEVICE, NAT |
| Baseline Model No | NA |
| Baseline Catalog No | 21117750 123 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-23 |