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 2016-12-28 for ADVIA 2400 manufactured by Siemens Healthcare Diagnostics Inc..
[63490716]
The customer contacted a siemens customer care center (ccc) specialist. The customer stated they received "k" and "/////" flags as their results. When a "/////" flag is displayed, a result is not to be reported out as this flag is a calculation error. As per the operator's guide for the advia 2400 states, "do not report as a result. Do not interpret as a result". However, the customer manually entered a result of 0. 01 g/l and reported this result to the physician(s). Siemens is investigation the event.
Patient Sequence No: 1, Text Type: N, H10
[63490717]
A flagged patient result for complement c3 on an advia 2400 instrument was reported out by the customer. The sample initially resulted "k" (exceeded the calibration low range flag) and "/////" (overflow flag - calculation error) flags. The same sample was repeated and resulted the same. The customer manually assigned a result and reported out the result to the physician(s), who questioned the result. The same sample was repeated on the same analyzer again, resulting higher. A corrected report was issued to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the flagged patient result being reported out.
Patient Sequence No: 1, Text Type: D, B5
[73846988]
The initial mdr 2432235-2016-00807 was filed on december 28, 2016. Additional information (03/21/2017): a siemens headquarters support center (hsc) reviewed the event. Hsc found this is not a method or reagent issue. A review of the customer's quality control (qc) showed that it was in at the time of the event. The cause of the flagged patient results is unknown but the cause of the flagged patient result being reported out is due to user error. 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 | 2432235-2016-00807 |
| MDR Report Key | 6211611 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-28 |
| Date of Report | 2017-04-12 |
| Date of Event | 2016-12-01 |
| Date Mfgr Received | 2017-03-21 |
| Date Added to Maude | 2016-12-28 |
| 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, 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 | CZW |
| Date Received | 2016-12-28 |
| 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 | 2016-12-28 |
| 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 | 2016-12-28 |