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 2017-08-23 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[83742134]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6). Phone was provided as "(b)(6)".
Patient Sequence No: 1, Text Type: N, H10
[83742135]
The customer received questionable low roche omni electrode potassium results for two samples from one patient. Sample 1 initial result was 4. 63 mmol/l. The result from a cobas 6000 c (501) module was 5. 11 mmol/l one arterial blood sample was used for both tests. Sample 2 on (b)(6) 2017, the initial result was 3. 95 mmol/l. The result from a cobas 6000 c (501) module was 4. 43 mmol/l one arterial blood sample was used for both tests. The erroneous results were reported outside the laboratory. The patient was not treated or injured by the event. The electrode lot number and expiration date were requested but were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01795 |
| MDR Report Key | 6812748 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-23 |
| Date of Report | 2018-04-04 |
| Date of Event | 2017-07-30 |
| Date Mfgr Received | 2017-08-04 |
| Date Added to Maude | 2017-08-23 |
| 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 | 2017-08-23 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-23 |