MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-06 for APTIO BY SIEMENS manufactured by Siemens Healthcare Diagnostics Inc..
[113638044]
The customer contacted the siemens customer care center (ccc) to report that a low creatinine (cre) test result was obtained on an aliquot from the primary sample tube on an aptio by siemens system. The customer found water in the aliquoter secondary tube on the aptio input/output module. The customer turned off the aliqoter. A siemens customer service engineer (cse) was dispatched to the site to inspect the system. The cse replaced a pipetter valve and pump. The cause of the low creatinine test result was the pipette valve and pump. The instrument is performing according to specifications. No further evaluation of this instrument is required.
Patient Sequence No: 1, Text Type: N, H10
[113638045]
A low creatinine (cre) test result was obtained on an aliquot from the primary sample tube on an aptio by siemens system. The initial result was reported to the physician(s). The primary sample was repeated and the repeat test result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the low creatinine test result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00413 |
| MDR Report Key | 7667635 |
| Date Received | 2018-07-06 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-06-15 |
| Date Mfgr Received | 2018-06-15 |
| Date Added to Maude | 2018-07-06 |
| 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 | 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 | 0 |
| Brand Name | APTIO BY SIEMENS |
| Generic Name | APTIO BY SIEMENS |
| Product Code | LXG |
| Date Received | 2018-07-06 |
| Model Number | APTIO BY SIEMENS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-06 |