MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2001-03-01 for VIDAS VIDAS 30 W2010 manufactured by Biomerieux, Inc..
[214104]
Lab noted after running controls that "rfv's" for section a2 (one of 30 pump positions) were much lower than the allowed range. Field svc was called to the site and replaced the pump motor assembly at which time the section functioned properly. Lab determined that the pump at position a2 had not been pumping properly for the period of time 8/7/00-8/10/00 during which time vidas assays had been run. Upon correction of the problem the lab performed repeat testing on 2 hiv samples, both of which gave the same results as originally reported, 3 hepatitis b samples, two of which gave the same results as originally reported and one of which that was originally reported as <10 iu retested at 10-100 iu. The three chlamydia samples were not retested as the samples had been discarded. Please note that the hiv and hepatitis b assays are not available for sale in the united states.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2001-00001 |
| MDR Report Key | 319228 |
| Report Source | 01 |
| Date Received | 2001-03-01 |
| Date of Report | 2001-03-01 |
| Date of Event | 2000-08-09 |
| Date Mfgr Received | 2001-01-18 |
| Device Manufacturer Date | 1992-04-01 |
| Date Added to Maude | 2001-03-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA PERREAND, DIRECTOR |
| Manufacturer Street | 595 ANGLUM DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318594 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NOT REQUIRED |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS |
| Generic Name | IMMUNOFLUOROMETER EQUIPMENT |
| Product Code | JZT |
| Date Received | 2001-03-01 |
| Model Number | VIDAS 30 |
| Catalog Number | W2010 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 308766 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 595 ANGLUM DR. HAZELWOOD MO 63042 US |
| Baseline Brand Name | VIDAS |
| Baseline Generic Name | IMMUNOFLUOROMETER EQUIPMENT |
| Baseline Model No | VIDAS 30 |
| Baseline Catalog No | W2010 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-03-01 |