MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-03-21 for ISE 9180 03157334001 manufactured by Roche Diagnostics.
[17074972]
Account experiencing getting erratic pt recovery for sodium starting 2007. No pt results were provided. The only data provided was from a reproducability study performed in 2008, which included fourteen sodium results from one pt sample. Initial result gave 136 mmol/l; sample repeated thirteen times giving 121, 135, 140, 137, 141, 138, 141, 132, 140, 111, 120, 137 & 132 mmol/l. No adverse events reported. If additional info is received, appropriate notification will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2008-02656 |
| MDR Report Key | 1019675 |
| Report Source | 05,06 |
| Date Received | 2008-03-21 |
| Date of Report | 2008-03-21 |
| Date of Event | 2008-02-26 |
| Date Facility Aware | 2008-02-27 |
| Report Date | 2008-02-27 |
| Date Mfgr Received | 2008-02-27 |
| Date Added to Maude | 2008-05-27 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | SALLY BOWDEN |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214668 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | KRATKYSTRASSE 2 |
| Manufacturer City | GRAZ A8020 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | A8020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISE 9180 |
| Generic Name | BLOOD GAS ANALYZER - JFP |
| Product Code | JFP |
| Date Received | 2008-03-21 |
| Model Number | ISE 9180 |
| Catalog Number | 03157334001 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1018690 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-21 |