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 2017-08-02 for STREAMLAB? ANALYTICAL WORKCELL manufactured by Siemens Healthcare Diagnostics Inc..
[81637876]
The siemens customer care center (ccc) dispatched the customer service engineer (cse) to the customer site. The cse examined the centrifuge module (cm) and determined that the refrigeration unit had failed. The cse installed a new ventilator and ac (air conditioning) compressor. The cse also verified the power supply and temperature alarms were operational. The cse installed the cm to the steramlab track and all alignments between the cm and streamlab were performing according to specifications. No further evaluation of this device was required and the cause of cardiac troponin i (ctni) discordant results on one patient sample is unknown.
Patient Sequence No: 1, Text Type: N, H10
[81637877]
The operator of the streamlab core unit called the siemens customer care center (ccc) to report an increased temperature in the centrifugation module (cm) and a cardiac troponin i (ctni) discordant low result with a patient sample which was run on a dimension vista instrument after being processed on the streamlab. The discordant result was reported to the physician(s). The operator informed the ccc that sample tubes were found to be bent when the cm robot tried to pick up the tube. The operator did not report any delays as other centrifuges were available offline. The sample was repeated and resulted higher and the repeat result was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00621 |
| MDR Report Key | 6761429 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-02 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-07-11 |
| Date Mfgr Received | 2017-07-11 |
| Date Added to Maude | 2017-08-02 |
| 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 | ROLANDO HUALPA |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242963 |
| Manufacturer G1 | INPECO S.P.A |
| Manufacturer Street | VIA GIVOLETTO 15 |
| Manufacturer City | VAL DELLA TORRE (TORINO), 10040 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 10040 |
| 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 | 2017-08-02 |
| Model Number | STREAMLAB? ANALYTICAL WORKCELL |
| 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 | 2017-08-02 |