MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-10 for ACCELERATOR A3600 ACP manufactured by Inpeco Sa.
[183327154]
A sample tube got stuck inside the robot gripper of the rack input module (rim) which is an automation system module which allows the movement of sample tubes from a rack to the automation sample carriers. When the gripper tried to place the tube into the carrier the error on the up-down robot movement was generated and the module stopped working. The error recovery required the intervention on the module and the customer contacted the service assistance. The involved tube was a square base tube which is not allowed on the automation system: the tube was erroneously placed into the rack loaded in the rim by the operator. The field service engineer removed the safety cover and tried to pull the tube out of the gripper. Doing so, he cut his finger with the gripper fingers. He was wearing ppe, including gloves. The cut did not require any medical treatment. A blood test was performed the day after the incident: all test results were negative. The blood tests will be repeated after 1 month, 3 months, 6 months and 12 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010825766-2020-00001 |
| MDR Report Key | 9575273 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2019-12-13 |
| Date Added to Maude | 2020-01-10 |
| 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 | ACCELERATOR A3600 |
| Generic Name | LABORATORY AUTOMATION SYSTEM |
| Product Code | CEM |
| Date Received | 2020-01-10 |
| Model Number | ACP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-10 |