MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-04-05 for FLEXLAB manufactured by Inpeco Sa.
[145784189]
Inpeco distributor is in charge of the service support activities on flexlab automation system installed at huslab. Specifically, inpeco distributor is responsible for the first assistance: in case a deeper investigation or a product design change is needed to fix the issue, inpeco distributor contacts inpeco service team. For the problem described in the customer report, inpeco has not been directly involved. At present the investigation is still ongoing and the root cause has not been identified yet. Inpeco is working with the distributor in order to get further information from the customer and reproduce, if possible, the problem in house.
Patient Sequence No: 1, Text Type: N, H10
[145784190]
The customer reported to the finnish competent authority an inadequate sample tubes management in case of abbott c16000 analyzer total timeout error message sent from the analyzer to the flexlab automation system that may lead to sample results mismatch and sample cross contamination. No incident has been reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010825766-2019-00003 |
| MDR Report Key | 8487386 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-04-05 |
| Date of Report | 2019-04-05 |
| Date of Event | 2018-10-25 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-04-05 |
| 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 | 2019-04-05 |
| Device Availability | Y |
| 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 | 2019-04-05 |