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 2017-11-27 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[92954496]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[92954497]
The customer complained that an operator was splashed in the face with blood from the sample port of the cobas b 221 instrument while injecting a patient sample via syringe. The patient was (b)(6)for (b)(6). There was also a splash of blood in the area surrounding the instrument including the ceiling. This area has been disinfected. The operator was wearing gloves and normal glasses at the time. The operator was not wearing goggles. The operator had blood from the splashed fluid all over the face and the face was washed with hot, soapy water. The operator appeared shocked after the event but appeared unharmed. The operator went to occupational health and received a hepatitis b vaccination and blood was taken for storage for 2 years. The operator had been trained on the instrument. The instrument had been operating without any problems up until the operator injected the sample. After the event, 6 blood samples were run on the instrument with no issues. The customer stated no maintenance related to the turn & dock (t&d) module or otherwise had been performed on the instrument prior to the event. No error messages were displayed on the instrument before or after the event. No error messages or problems were detected related to the waste separator. The field service engineer (fse) visited the customer site and ran 3 levels of quality control on the instrument with acceptable results. The fse checked the t&d module and it was in good condition. The fse replaced the fill port and needle due to contamination.
Patient Sequence No: 1, Text Type: D, B5
[109122608]
Device information was corrected.
Patient Sequence No: 1, Text Type: N, H10
[109124274]
Annual preventive maintenance was performed on 27-jun-2017. As of 15-feb-2018 the customer is running the instrument.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-02742 |
| MDR Report Key | 7059720 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-27 |
| Date of Report | 2018-04-30 |
| Date of Event | 2017-11-10 |
| Date Mfgr Received | 2017-11-10 |
| Date Added to Maude | 2017-11-27 |
| 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 | 2017-11-27 |
| 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 | 1. Other | 2017-11-27 |