MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-16 for VIDAS 30 IMMUNOASSAY ANALYZER manufactured by Biomerieux Vitek, Inc..
[16401492]
On 7/5/95, a field rep from the mfr discovered an intermittent partial obstruction of one (1) channel of the instrument assembly due to a portion of a solid phase pipette cap cover. This is a unique failure that could not be detected by standard quality control procedures recommended by the mfr and usually performed by the institution. The end result of the instrument failure was seventeen (17) possible false positive test results for chlamydia trachomatis covering the time period from 5/12/96 to 7/7/96. Appropriate steps are being taken to notify the pts and their physicians.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009502 |
| MDR Report Key | 34172 |
| Date Received | 1996-07-16 |
| Date of Report | 1996-07-15 |
| Date Added to Maude | 1996-07-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS 30 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | LJC |
| Date Received | 1996-07-16 |
| Returned To Mfg | 1996-07-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35532 |
| Manufacturer | BIOMERIEUX VITEK, INC. |
| Manufacturer Address | 595 ANGLUM DR HAZELWOOD MO 630422395 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-07-16 |