MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-08-22 for ROCHE OMNI ELECTRODE POTASSIUM 03111628180 manufactured by Roche Diagnostics.
[118100163]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[118100164]
The customer questioned results for 3 patients tested for potassium (k) on a cobas b 221 system. Based on the data provided, the results for 1 patient are a reportable malfunction. The initial result at 5:59 a. M. Was 6. 34 mmol/l. The same sample was repeated at 6:08 a. M. And the result was 7. 21 mmol/l. These results were reported outside of the laboratory but the physician dismissed them and no clinical decisions were made. There was no allegation that an adverse event occurred. The b 221 instrument serial number was (b)(4). The k electrode was requested for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02815 |
| MDR Report Key | 7804341 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-22 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-08-05 |
| Date Mfgr Received | 2018-08-06 |
| Date Added to Maude | 2018-08-22 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROCHE OMNI ELECTRODE POTASSIUM |
| Generic Name | ELECTRODE, ION SPECIFIC, POTASSIUM |
| Product Code | CEM |
| Date Received | 2018-08-22 |
| Model Number | NA |
| Catalog Number | 03111628180 |
| Lot Number | 21574849 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-22 |