MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-11-01 for ADVIA 2400 manufactured by Siemens Healthcare Diagnostics Inc..
[91222351]
A siemens healthcare diagnostics inc. (siemens) customer service engineer (cse) was dispatched to the customer site to inspect the system. The cse analyzed the system and found that it would not initialize. The cse replaced the reagent pump 1 (rp1), pulse motor controller driver board for rp1 and the water pressure pump and initialized the system. The cause of the discordant ggt result is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[91222352]
A discordant gamma glutamyl transferase (ggt) patient sample test result was obtained on an advia 2400 system. The initial result was not reported to the physician(s). The same sample was repeated on an alternate advia 2400. The repeat result was reported to the physician(s). The repeat test result was not provided by the customer to siemens and is not available for this report. There are no known reports of patient intervention or adverse health consequences due to the discordant ggt result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00592 |
| MDR Report Key | 6994494 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-01 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-10-11 |
| Date Added to Maude | 2017-11-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| 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 2400 |
| Generic Name | ADVIA 2400 |
| Product Code | JPZ |
| Date Received | 2017-11-01 |
| Model Number | ADVIA 2400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-01 |