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 2019-01-11 for APTIO BY SIEMENS 10703031 manufactured by Dimension Siemens Healthcare Diagnostics Inc..
[133390563]
The customer contacted the siemens customer care center to report the aliquoter module on the aptio by siemens automation system was continuously attempting to load secondary tubes and not processing primary sample tubes causing a delay in routine patient testing. The aliquoter module did not generate an error message. Nine patient sample tubes were discarded and new samples were drawn. A siemens customer service engineer (cse) was dispatched to the site to inspect the instrument. A defective sensor in the aliquoter module was identifed and replaced. The cause of the delay in testing was a defective sensor in the aliquoter module. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[133390564]
The customer contacted the siemens customer care center to report an issue with the aliquoter module on an aptio by siemens automation system. Patient sample testing was delayed for several hours by the issue. Nine patient samples were not processed during the delay. The samples were discarded and new samples were drawn and processed. There are no known reports of patient intervention or adverse health consequences due to the delay in testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2019-00020 |
| MDR Report Key | 8241465 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-11 |
| Date of Report | 2019-01-11 |
| Date of Event | 2018-12-20 |
| Date Mfgr Received | 2018-12-21 |
| Date Added to Maude | 2019-01-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | INPECO S.P.A |
| Manufacturer Street | VIA GIVOLETTO 15 ITALY REGISTRATION #: 30055092 |
| Manufacturer City | 10040 VAL DELLA TORRE (TORINO), |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APTIO BY SIEMENS |
| Generic Name | APTIO BY SIEMENS |
| Product Code | LXG |
| Date Received | 2019-01-11 |
| Model Number | APTIO BY SIEMENS |
| Catalog Number | 10703031 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIMENSION SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-11 |