MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2001-05-24 for VIDAS W1020 manufactured by Biomerieux, Inc..
[222850]
During a scheduled preventative maintenance check at the account the field service engineer performed a standard diagnostic check (qct check) and the instrument failed the test. The pump was replaced and it was determined that the pump had a clogged pump tube in position c1. Test results for the period of 3/2/2001-05/10/2001 are being evaluated to determine if pt results are affected.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1950204-2001-00007 |
MDR Report Key | 335469 |
Report Source | 01 |
Date Received | 2001-05-24 |
Date of Report | 2001-05-21 |
Date of Event | 2001-05-11 |
Date Mfgr Received | 2001-05-11 |
Device Manufacturer Date | 1991-08-01 |
Date Added to Maude | 2001-06-04 |
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 | RP |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VIDAS |
Generic Name | IMMUNOFLUROMETER EQUIPMENT |
Product Code | JZT |
Date Received | 2001-05-24 |
Model Number | NA |
Catalog Number | W1020 |
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 | 324816 |
Manufacturer | BIOMERIEUX, INC. |
Manufacturer Address | 595 ANGLUM DRIVE HAZELWOOD MO 63042 US |
Baseline Brand Name | VIDAS |
Baseline Generic Name | IMMUNOFLUROMETER EQUIPMENT |
Baseline Model No | NA |
Baseline Catalog No | W1020 |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2001-05-24 |