MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2015-01-06 for ISE 9180 05110394001 manufactured by Roche Diagnostics.
[5429606]
The customer complained of a questionable ion selective electrode sodium result. The initial result was 90 mmol/l. The repeat result was 123 mmol/l. Information regarding which results were reported outside the laboratory and whether the patient was harmed was requested but not provided. The lot number and expiration date of the sodium electrode were requested but not provided. The field service representative determined the analyzer was not appropriately grounded. After the customer corrected the grounding issue, samples were tested and the results were acceptable. The field service representative determined the analyzer was working properly.
Patient Sequence No: 1, Text Type: D, B5
[12730832]
The event took place in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[12865086]
There were no adverse events. Only the 123 mmol/l result was reported outside the laboratory.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-00058 |
| MDR Report Key | 4386781 |
| Report Source | 01,05,06,07 |
| Date Received | 2015-01-06 |
| Date of Report | 2015-01-21 |
| Date of Event | 2014-12-12 |
| Date Mfgr Received | 2014-12-12 |
| Date Added to Maude | 2015-01-06 |
| 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 MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| 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 | 2015-01-06 |
| Model Number | NA |
| Catalog Number | 05110394001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-01-06 |