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 2018-03-12 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[102225427]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102225428]
The customer complained of erroneous high results for 2 patients tested for sodium on a cobas b 221 instrument compared to a cobas 6000 c (501) module. Patient 1 initial sodium result from the b 221 instrument at 3:55 p. M. Was 176. 7 mmol/l. A fresh, venous sample was obtained for the c501 module and the result at 4:12 p. M. Was 139 mmol/l. Patient 2 (male, (b)(6)) initial sodium result from the b 221 instrument at 6:53 p. M. Was 174. 3 mmol/l. A fresh, venous sample was obtained for the c501 module and the result at 7:41 p. M. Was 140 mmol/l. Neither patient was treated incorrectly nor were they adversely affected. The sodium electrode lot number and expiration date were not provided. The reference electrode and the sodium electrode were both installed on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00766 |
| MDR Report Key | 7330493 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-12 |
| Date of Report | 2018-06-11 |
| Date of Event | 2018-02-18 |
| Date Mfgr Received | 2018-02-22 |
| Date Added to Maude | 2018-03-12 |
| 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 | 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 S |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2018-03-12 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-03-12 |