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 2017-11-03 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[92071479]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[92071480]
The customer received questionable sodium and potassium results for at least four patient samples. The erroneous results were reported outside of the laboratory to the medical personnel who rejected the results and asked the laboratory to repeat testing. The repeat testing was performed approximately one hour later on the same analyzer. (b)(6). There was no allegation of an adverse event. The reagent lot numbers and expiration dates were requested but were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02518 |
| MDR Report Key | 6999307 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-03 |
| Date of Report | 2018-04-04 |
| Date of Event | 2017-10-18 |
| Date Mfgr Received | 2017-10-18 |
| Date Added to Maude | 2017-11-03 |
| 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 | 2017-11-03 |
| 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 | 2017-11-03 |