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 2017-12-19 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[95836351]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[95836352]
The customer received questionable po2 results for one patient sample. The patient used o2 (4 lit/m and through venturi filter mask) and the po2 was measured by monitor dash 4000 and was 94-95 mmhg. The result from the cobas b 221 was 122. 6 mmhg. Another sample was drawn from the patient and the result was 77. 5 mmhg. The sample was tested on another cobas b221 and the result was 70. 8 mmhg. These results were believed to be correct. No erroneous result was reported outside of the laboratory. There was no allegation of an adverse event. The po2 electrode lot number and expiration date were requested but were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-03035 |
| MDR Report Key | 7130840 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-19 |
| Date of Report | 2018-04-04 |
| Date of Event | 2017-12-10 |
| Date Mfgr Received | 2017-12-11 |
| Date Added to Maude | 2017-12-19 |
| 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 | 2017-12-19 |
| 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 | 2017-12-19 |