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 W2010 manufactured by Biomerieux, Inc..
[21590420]
Customer reported "wrong results" in position c2 (one of 30 pump positions on the instrument) in that the standards were outside of the range and much lower than the standard run on position c1. In addition, occasionally position c1 was low and outside of the range. The next morning field service was contacted and went to the site at which time the pump was replaced and the instrument was placed back in service. Customer reviewed records and identified suspect assays that had been run between the last preventative maintenance on 12/17/00 and 1/25/01. If pt samples were available they were retested. If they were not available pts were contacted via consultants and gp's and advised to return for repeat testing. The results of the retests were as follows: hiv 20/30 retested. All - originally, all - on repeat. Hepatitis b antigen 10/31 retested. All - originally, all - on repeat. Hepatitis b antibody 13/32 retested, all - originally, 10+ on repeat 3 - on repeat. Hepatitis w/rubella (screening), 27/30, all - originally, all - on repeat. Hepatitis b marker, 1/6 retested, all - originally, all - on retest. Rubella, 41/64 retested, all - originally, 37 + on retest, 4 - on retest. Varicella zoster, 0/3 retested. Cmv, 1/2 retested, - originally, - on retest. Hepatitis a, 3/3 retested, all - originall, all - on retest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2001-00002 |
| MDR Report Key | 319218 |
| Report Source | 01 |
| Date Received | 2001-03-01 |
| Date of Report | 2001-03-01 |
| Date of Event | 2001-01-25 |
| Date Mfgr Received | 2001-01-25 |
| Device Manufacturer Date | 1991-10-01 |
| 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 |
| 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 | IN |
| 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 | NA |
| 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 | 308758 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 595 ANGLUM DR. HAZELWOOD MO 63042 US |
| Baseline Brand Name | VIDAS |
| Baseline Generic Name | IMMUNOFLUOROMETER EQUIPMENT |
| Baseline Model No | NA |
| Baseline Catalog No | W2010 |
| Baseline ID | NA |
| Baseline Device Family | VIDAS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K923579 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-03-01 |