MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2009-12-16 for COBAS INTEGRA 400 PLUS I400+ 03245233001 manufactured by Roche Diagnostics.
[1450990]
The user stated they performed an ethanol for one pt sample from the last measurement from the reagent cassette and a value of 0. 9 was obtained. The doctor didn't believed the result and asked for a retest. The user loaded a new reagent cassette and performed calibration. The repeat result for the pt was then 57. No units of measure were provided. No info was provided to determined if the pt was adversely affected. If add'l info is received, appropriate notification will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2009-08512 |
| MDR Report Key | 1564504 |
| Report Source | 01,05,06 |
| Date Received | 2009-12-16 |
| Date of Report | 2009-12-16 |
| Date of Event | 2009-12-02 |
| Date Facility Aware | 2009-12-02 |
| Report Date | 2009-12-02 |
| Date Mfgr Received | 2009-12-02 |
| Date Added to Maude | 2010-02-12 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG |
| Manufacturer Street | TEGIMENTA FORRENSTRASSE |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA 400 PLUS |
| Generic Name | CLINICAL CHEMISTRY ANALYZER - JJE |
| Product Code | DIC |
| Date Received | 2009-12-16 |
| Model Number | I400+ |
| Catalog Number | 03245233001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-16 |