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 2017-09-08 for STREAMLAB? ANALYTICAL WORKCELL manufactured by Siemens Healthcare Diagnostics Inc.
[85752927]
The customer contacted the siemens customer care center (ccc). The customer reported that another patient sample (b)(6) was the next sample to be run, and it ran as expected. The customer purged all samples from streamlab and performed controlled shutdown and reboot. Upon follow up with the customer, it was determined that the cause of the results being reported out for the sample, before it was drawn, was due to a user error. The barcode label was placed on an incorrect tube by an operator at the facility. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[85752928]
The operator of a streamlab automation system reported that results for a patient sample (b)(6), which has not been drawn yet, were generated and reported out. An order was placed for the samples and was scheduled for glucose, urea nitrogen, blood (bun), creatinine_2, potassium, sodium, chloride, calcium, carbon dioxide, total protein, albumin, aspartate aminotransferase, alanine aminotransferase, total bilirubin and alkaline phosphatase testing. The customer reported that the discordant results were not acted upon, and the corrected results were reported to the physician(s) by testing the correct sample. There are no reports of patient intervention or adverse health consequences due to the mismatch of sample id.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00694 |
| MDR Report Key | 6853031 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-08 |
| Date of Report | 2017-09-08 |
| Date of Event | 2017-08-15 |
| Date Mfgr Received | 2017-08-15 |
| Date Added to Maude | 2017-09-08 |
| 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 AVE |
| 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 REGISTRATION# 3005509212 |
| 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 | 2017-09-08 |
| 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 | 2017-09-08 |