MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2001-11-12 for MINIVIDAS W2011 manufactured by Biomerieux, Inc..
[221143]
Customer was running "qct" test strips on pump and failed the test 4 times. Qcr test is a test to detect clogged pump tubes. Clogged pump tubes could result in false results being reported to the pt. There are no reports of false results being generated at this site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2001-00016 |
| MDR Report Key | 360507 |
| Report Source | 01 |
| Date Received | 2001-11-12 |
| Date of Report | 2001-11-12 |
| Date of Event | 2001-10-08 |
| Date Mfgr Received | 2001-10-08 |
| Device Manufacturer Date | 1994-12-01 |
| Date Added to Maude | 2001-11-20 |
| 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 | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINIVIDAS |
| Generic Name | IMMUNOFLUROMETRIC EQUIPMENT |
| Product Code | IZT |
| Date Received | 2001-11-12 |
| Model Number | MINIVIDAS |
| Catalog Number | W2011 |
| 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 | 349676 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 595 ANGLUM DR. HAZELWOOD MO 63042 US |
| Baseline Brand Name | MINIVIDAS |
| Baseline Generic Name | IMMUNOFLUROMETRIC EQUIPMENT |
| Baseline Model No | MINIVIDAS |
| Baseline Catalog No | W2010 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-11-12 |