MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-03-12 for ISE 9180 03157334001 manufactured by Roche Diagnostics.
[1290150]
The user received analyzer alarms and discrepant lithium results for one patient sample. The results were 1. 02, 0. 98, 0. 94, 1. 07, 0. 85 and 0. 98 mmol/l. The patient results were not reported and no actions were taken based on the results. The lot number of the lithium electrode was not provided. Investigation determined the cause was a defective mainboard and reference valve which were replaced. The analyzer operation was verified by a sample sensor test, service testing, adjustments and qc testing with all results passing.
Patient Sequence No: 1, Text Type: D, B5
[8597065]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-01570 |
| MDR Report Key | 1629515 |
| Report Source | 05,06 |
| Date Received | 2010-03-12 |
| Date of Report | 2010-03-12 |
| Date of Event | 2010-02-23 |
| Date Mfgr Received | 2010-02-23 |
| Date Added to Maude | 2010-03-12 |
| 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 | NA ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | KRATKYSTRASSE 2 NA |
| Manufacturer City | GRAZ A8020 |
| Manufacturer Postal Code | A8020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISE 9180 |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JFP |
| Date Received | 2010-03-12 |
| Returned To Mfg | 2010-03-04 |
| Model Number | NA |
| Catalog Number | 03157334001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-12 |