MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-11-25 for ISE 9180 03157334001 manufactured by Roche Diagnostics.
[15612480]
The customer was running samples as part of troubleshooting a problem with control recovery for lithium and sodium assays when they received discrepant calcium results for one pt sample. The calcium assay was not in question during the troubleshooting and was run because the user needed the calcium results. After running the samples, the customer then questioned the calcium results since they had already determined the lithium and sodium assays were not working properly based upon quality control results. The pt sample was run six times giving the following calcium results: 5. 22, 5. 20. 5. 14, 5. 06, 3. 94 and 5. 15 mg/dl. If add'l info is received, appropriate notification will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2008-08730 |
| MDR Report Key | 1249823 |
| Report Source | 05,06 |
| Date Received | 2008-11-25 |
| Date of Report | 2008-11-25 |
| Date of Event | 2008-11-12 |
| Date Facility Aware | 2008-11-12 |
| Report Date | 2008-11-12 |
| Date Mfgr Received | 2008-11-12 |
| Date Added to Maude | 2009-04-14 |
| 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 | 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 | 2008-11-25 |
| Model Number | ISE 9180 |
| Catalog Number | 03157334001 |
| 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 | 2008-11-25 |