MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-24 for STREAMLAB? ANALYTICAL WORKCELL manufactured by Siemens Healthcare Diagnostics Inc..
[73733519]
A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the instrument, the cse installed a new diverter gate and verified the functioning of the instrument. The customer stated that the issue may have occurred due to the failure of the diverter gate. The cause of the incorrect results being transmitted to the streamlab analytical workcell system is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[73733520]
The customer of a streamlab? Analytical workcell system contacted a siemens customer care center (ccc). The customer stated that a patient sample was delivered to the priority output lane with a "possible wrong result" message. Each specimen is assigned to a pallet with a specific identification number, which has an expected order. The pallet for the sample in question arrived at the subsequent tag reader that was not expected by the streamlab. As a result, the sample was sent to a priority output lane by the analyzer with the flag of possible wrong result. The customer reran the sample and the results transmitted to the laboratory information system were incorrect as suspected. The incorrect results were reported to the physician(s). The customer ordered the tests manually and front loaded the sample on the dimension vista instrument, resulting acceptable. The corrected 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
[75937550]
The initial mdr 2517506-2017-00431 was filed on april 24, 2017. Additional information (04/25/2017): a siemens headquarters support center specialist reviewed the service report and concluded that the failure of the diverter gate allowed the delivery and sampling of the incorrect tube. The misdirection of the sample was detected by the streamlab? Analytical workcell system and the misdirected tubes were identified by the dimension vista instrument. The misdirected tubes were then flagged with "possible wrong result" message and delivered to priority output rack. As stated in the initial mdr, the siemens customer service engineer replaced the diverter gate, which resolved the issue. The cause of the incorrect results being transmitted to the streamlab analytical workcell system was a malfunction of the diverter gate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2017-00431 |
| MDR Report Key | 6516669 |
| Date Received | 2017-04-24 |
| Date of Report | 2017-05-12 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2017-04-25 |
| Date Added to Maude | 2017-04-24 |
| 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 | 2017-04-24 |
| 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 | 2017-04-24 |