MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-06-01 for STREAMLAB? ANALYTICAL WORKCELL manufactured by Siemens Healthcare Diagnostics Inc..
[76630376]
A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the device, the cse performed maintenance of the track and side track area of the dimension vista analyzer. The cse then cleaned and replaced the stop gates at the divert location and sample position gates. The cse also cleaned the tube barcode readers at the divert gate and re-booted the dimension vista analyzer and streamlab? Analytical workcell system. The dimension vista analyzer was brought back on line and observed sample processing off of the track. Streamlab? Analytical workcell system is processing samples properly. This issue has not reoccurred since the service visit. The cause of the incorrect sample tube being processed is unknown. The device is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[76630377]
The customer obtained "possible wrong results" error flag on one patient sample on a streamlab? Analytical workcell system as a result of an incorrect sample tube being processed on a dimension vista analyzer. Sample id (b)(6) was sampled from the track and the results obtained were associated to sample id (b)(6). The incorrect results were not reported to the physician(s). Sample tube (b)(6) was then front loaded and processed on the dimension vista analyzer, resulting different from the initial results. It is unknown if the correct results were reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the incorrect results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00459 |
| MDR Report Key | 6605740 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-01 |
| Date of Report | 2017-07-14 |
| Date of Event | 2017-05-09 |
| Date Mfgr Received | 2017-06-20 |
| Date Added to Maude | 2017-06-01 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | INPECO S.P.A |
| Manufacturer Street | VIA GIVOLETTO 15 |
| 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 | STREAMLAB? ANALYTICAL WORKCELL |
| Generic Name | STREAMLAB? ANALYTICAL WORKCELL |
| Product Code | LGX |
| Date Received | 2017-06-01 |
| Model Number | STREAMLAB? ANALYTICAL WORKCELL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-06-01 |