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 2018-03-02 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[101700928]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101700929]
The customer stated that they received questionable low results for an unspecified number of patient samples tested for partial pressure of oxygen (po2) on the cobas b 221<6>=roche omni s6 system (b221) in the critical care unit. The customer provided data for five patient samples that had erroneous po2 results. Erroneous results are reported outside of the laboratory. Po2 was the only test parameter that was affected. All samples were initially tested on the b221 analyzer and the po2 results were low. The samples were repeated on a second b221 analyzer used in the laboratory. The fifth patient sample was tested after deproteinizer and system reagents were changed on both analyzers. Samples are injected into the analyzer and they make sure there is no air in them. The lot number and expiration date of the po2 electrode/cartridge was asked for, but not provided. The field service engineer checked the analyzer. He ran a patient sample comparison after checking the analyzer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00630 |
| MDR Report Key | 7309151 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-02 |
| Date of Report | 2018-09-13 |
| Date of Event | 2018-02-13 |
| Date Mfgr Received | 2018-02-13 |
| Date Added to Maude | 2018-03-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-03-02 |
| 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 | 2018-03-02 |