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 2015-05-04 for ISE 9180 03157334001 manufactured by Roche Diagnostics.
[5709834]
The customer reported that they received questionable results for an unknown number of patient samples tested for ion selective electrode (ise) tests. Data was provided for one patient sample and for this sample, there were erroneous ise sodium and ise potassium results. The sample initially resulted as 115 mmol/l for ise sodium and 5. 9 mmol/l for ise potassium. The physical condition of the patient did not match the initial results, so the sample was repeated. The sample was repeated on a cobas b221 analyzer, resulting as 148. 4 mmol/l accompanied by a data flag for ise sodium and 4. 34 mmol/l for ise potassium. The patient was not adversely affected. The ise sodium electrode lot number was 306270. The ise potassium electrode lot number was 298689. The electrode expiration dates were asked for, but not provided. The sample probe,fill port, and electrode contact pins of the analyzer were cleaned. Maintenance and calibrations were also performed on the instrument. Results were said to be comparable after these actions were completed. No further result data was provided.
Patient Sequence No: 1, Text Type: D, B5
[13436481]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[13447940]
A specific root cause could not be determined. Investigations did determine that the customer did not run quality control material to check the instrument performance. Product labeling recommends routine use of quality controls.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03408 |
| MDR Report Key | 4746531 |
| Report Source | 01,05,06 |
| Date Received | 2015-05-04 |
| Date of Report | 2015-05-19 |
| Date of Event | 2015-04-20 |
| Date Mfgr Received | 2015-04-20 |
| Date Added to Maude | 2015-05-04 |
| 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 | 2015-05-04 |
| Model Number | NA |
| Catalog Number | 03157334001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | NURSE |
| 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 | 2015-05-04 |