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 2017-06-28 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[78609363]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[78609365]
The customer stated that they obtained results for one patient sample using the cobas b 221<6>=roche omni s6 system (b221) (sample id (b)(6)). The results were sent from the b221 analyzer to the cobas infinity system database. The customer then analyzed a different patient sample (sample id (b)(6)). They noticed that the results in the database corresponded to the previous sample, and did not match the results provided by the analyzer. Information was provided that the results were validated and released outside of the laboratory. The customer stated that the issue happens when the sample id is equal to the patient id of the last sample processed. When this occurs, the b221 analyzer appears to change the sample id. The customer has had to manually edit results in the infinity database system due to the issue. There was no allegation that an adverse event occurred. Further information was requested for investigation, and investigation activities are ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01356 |
| MDR Report Key | 6672809 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-28 |
| Date of Report | 2018-04-04 |
| Date of Event | 2017-06-13 |
| Date Mfgr Received | 2017-06-13 |
| Date Added to Maude | 2017-06-28 |
| 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 | 2017-06-28 |
| 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 | 2017-06-28 |