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 2017-08-07 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[83299502]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83299503]
The customer complained of erroneous results for 1 patient sample tested for sodium (na) on a cobas b 221 system. The initial na result was 146 mmol/l. This result was reported outside of the laboratory and the doctor did not accept the result. The sample was repeated and the result was 173 mmol/l. Clarification was requested to confirm that the results of 146 mmol/l and 173 mmol/l were from the same sample. This information has not been provided. Clarification was requested to confirm which result was considered to be incorrect. This information has not been provided. The customer stated they have been questioning results for 10 other patients tested for na and potassium (k) and are not reporting results from these parameters outside of the laboratory. The customer provided na and k results for 8 other patients. It is not known if repeat testing was performed. No repeat results have been provided. It is not known if an adverse event occurred. No adverse events were alleged. The na electrode was last changed on (b)(6) 2017 during the last annual maintenance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01623 |
| MDR Report Key | 6770438 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-07 |
| Date of Report | 2018-04-04 |
| Date of Event | 2017-07-11 |
| Date Mfgr Received | 2017-07-11 |
| Date Added to Maude | 2017-08-07 |
| 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 | 2017-08-07 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-07 |