MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-12-22 for COBAS B 221 6 ROCHE OMNI S6 SYSTEM 03337154001 manufactured by Roche Diagnostics.
[12914241]
Date received by manufacturer - it has been confirmed that the date received by the manufacturer is (b)(6) 2014. The involved patient was not adversely affected. No results were reported outside of the laboratory.
Patient Sequence No: 1, Text Type: N, H10
[14208506]
It was determined that the sensor was older than 28 days, which is outside of specifications, therefore, results from the cobas b 221 analyzer were not valid.
Patient Sequence No: 1, Text Type: N, H10
[21846099]
According to the nurses in the icu at this customer site, they have had an ongoing issue with results from an unspecified number of patient samples when results are compared between a cobas b221 analyzer and a cobas b 123 analyzer. Results are completely different from one analyzer to the next. The customer only provided information for one patient sample tested for ph. Control recovery on both analyzers has been comparable. This medwatch is being filed for the cobas b221 analyzer. Refer to the medwatch with a1. Patient identifier (b)(6) for the report on the cobas b123 analyzer. When the affected sample was run on the cobas b123 analyzer, the ph result was 7. 6. The sample was then tested for ph immediately after on a cobas b221 analyzer, resulting as 7. 447. It was asked, but it is not known if erroneous results were reported outside of the laboratory or if the patient was adversely affected. No adverse events were alleged.
Patient Sequence No: 1, Text Type: D, B5
[22219628]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-10340 |
| MDR Report Key | 4353686 |
| Report Source | 01,05,06 |
| Date Received | 2014-12-22 |
| Date of Report | 2015-07-14 |
| Date of Event | 2014-12-04 |
| Date Mfgr Received | 2014-12-04 |
| Date Added to Maude | 2014-12-22 |
| 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 | 0 |
| 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 | COBAS B 221 6 ROCHE OMNI S6 SYSTEM |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2014-12-22 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-22 |