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 2017-03-13 for ADVIA CHEMISTRY XPT manufactured by Siemens Healthcare Diagnostics Inc..
[69905760]
The customer contacted a siemens customer care center (ccc) specialist. The ccc reviewed the data provided. The ccc found the customer's quality control (qc) was in range at the time of the event. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse checked alignments on mixers and probes, resulting within specifications. The cse found an intermittent drip on the wash up and down nozzle r7. The cse replaced the nozzle and check valves on wash pump 1. Siemens is investigating the event.
Patient Sequence No: 1, Text Type: N, H10
[69905761]
A discordant, falsely depressed total protein concentrate result was obtained on a patient sample on an advia chemistry xpt instrument. The initial result was reported out to the physician(s), which was questioned. The customer repeated the same sample on an alternate instrument, resulting lower. The customer repeated the same sample on another alternate instrument, confirming the second result. The repeat result was reported out to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed total protein concentrate result.
Patient Sequence No: 1, Text Type: D, B5
[75234830]
The initial mdr 2432235-2017-00192 was filed on march 13, 2017. Additional information (03/16/2017): a siemens customer service engineer (cse) was dispatched to the customer's site. The cse aligned reagent probes to trays. The cse found a leak on wash nozzle 6. The cse flushed probe wash 3 through nozzle, resolving the leak from wash nozzle 6. No further issues have been reported related to this event. The cause of the discordant, falsely depressed total protein concentrate result is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2017-00192 |
| MDR Report Key | 6401505 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-13 |
| Date of Report | 2017-05-04 |
| Date of Event | 2017-02-13 |
| Date Mfgr Received | 2017-03-16 |
| Date Added to Maude | 2017-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION #: 3003637681 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO, 196-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-8558 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY XPT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JGQ |
| Date Received | 2017-03-13 |
| Model Number | ADVIA CHEMISTRY XPT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE. TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA CHEMISTRY XPT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-13 |
| Model Number | ADVIA CHEMISTRY XPT |
| 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 | 511 BENEDICT AVE. TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-13 |