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 2016-10-25 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[58355686]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[58355687]
A user complained that after running a sample on the cobas b 221 instrument, the instrument "expelled" some of the sample from the fill port. The blood from the sample got on her face. The sample was in a syringe and injected into the instrument by the user. The user was wearing work clothes, gloves and protective glasses. The user was trained on this instrument 8 years ago. The user injected the blood and she listened for the beep indicating the sample was received. The "remove the container" prompt came on the screen of the instrument. The user removed the container and the id screen didn't show and the turn and dock module where the sample port is didn't turn. A splash ("large volume") came from the fill port. The user is being treated with azidothymidine (azt). The one user affected stated this has happened to some others a long time ago but was unable to provide any information about when this occurred and who was affected. After this event, the cobas b 221 instrument processed more samples with no issue. The field service engineer (fse) checked the instrument including the turn and dock module and did not identify any issues. One day prior to the event preventive maintenance was performed.
Patient Sequence No: 1, Text Type: D, B5
[65487444]
A specific root cause could not be identified. Based on the information provided for investigation, no instrument malfunction was identified related to the issue the customer complained about. Based on the data provided by the customer, the system flagged ise and mms test parameters for insufficient sample which indicates the complete sample was not aspirated by the system as expected. Experiments were performed at the investigation site in an attempt to reproduce the customer issue. It was not possible to reproduce the customer's issue using the instructions for use in product labeling. Light back-flows from the fill port could only be reproduced by simulating a user handling error (e. G. Injecting the sample from the syringe when aspiration mode was selected on the instrument. ) during this user handling error simulation, the same sample flagging pattern was observed as seen with the customer's data. This suggests a user handling issue at the customer site. Even though the issue was only reproduced when the instrument was not used as intended, the sample was still not expelled strongly enough to splash onto a user's face. It is not known what other type of fluid other than the injected fluid could be expelled.
Patient Sequence No: 1, Text Type: N, H10
[106986778]
Patient Sequence No: 1, Text Type: N, H10
[109123887]
Device information was corrected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01621 |
| MDR Report Key | 6055256 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-25 |
| Date of Report | 2018-04-04 |
| Date of Event | 2016-10-04 |
| Date Mfgr Received | 2016-10-04 |
| Date Added to Maude | 2016-10-25 |
| 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 | 2016-10-25 |
| 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 | 2016-10-25 |