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 2017-05-29 for ADVIA 2400 manufactured by Siemens Healthcare Diagnostics Inc..
[76149293]
The customer contacted a siemens customer care center (ccc) specialist. The ccc reviewed the data provided. The ccc found that service was at the customer's site for a service call. The customer service engineer (cse) copied the settings from another advia from the customer's site to the advia 2400, correcting the issue that the cse was dispatched for. The ccc corrected the system parameters to the correct specification, as defined in the instructions for use (ifu). The ccc reviewed results and did not find any patient samples affected by this event. The cause of the incorrect parameters for amphetamines is human error. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[76149294]
Customer reported the parameters for amphetamines on their advia 2400 instrument were changed during a service visit. There are no known reports of patient intervention or adverse health consequences due to the incorrect parameters for amphetamines.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00335 |
| MDR Report Key | 6597217 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-29 |
| Date of Report | 2017-07-07 |
| Date of Event | 2017-04-20 |
| Date Mfgr Received | 2017-06-09 |
| Date Added to Maude | 2017-05-29 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION #: 3003637681 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO, JAPAN 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKZ |
| Date Received | 2017-05-29 |
| Model Number | ADVIA 2400 |
| 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 2400 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-05-29 |
| Model Number | ADVIA 2400 |
| 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 | 2017-05-29 |