MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-05 for FLEXLAB manufactured by Inpeco Sa.
[183322736]
The labeling has been reviewed and considered appropriate. In the operations manual it has already recommended to use caution when accessing parts of the module normally protected by covers since sharp surfaces can be reached. In the cobas 8000 interface module section there is a warning to advise the operators about the cutting hazard due to the sharp surface of the robot gripper. The health conditions of the fse will be kept monitored.
Patient Sequence No: 1, Text Type: N, H10
[183322737]
A field service engineer got a cut on his hand while he was working on the cobas 8000 interface module (im) to fix a malfunction of the im robot gripper which moves uncapped tubes. When the injury occurred the fse was wearing ppe, but the gripper fingers pierced the gloves. The cut was disinfected and bandaged. A blood test was immediately performed: all test results were negative. The blood tests will be repeated after 3 months and 6 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010825766-2020-00003 |
| MDR Report Key | 9792268 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-03-05 |
| 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 | MS EVA BALZAROTTI |
| Manufacturer Street | VIA TORRACCIA 26 |
| Manufacturer City | NOVAZZANO, 6883 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6883 |
| Manufacturer G1 | INPECO SPA |
| Manufacturer Street | VIA GIVOLETTO 15 |
| Manufacturer City | VAL DELLA TORRE, 10040 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 10040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXLAB |
| Generic Name | LABORATORY AUTOMATION SYSTEM |
| Product Code | CEM |
| Date Received | 2020-03-05 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INPECO SA |
| Manufacturer Address | VIA TORRACCIA 26 NOVAZZANO, 6883 SZ 6883 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-05 |