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 2017-06-27 for ADVIA CHEMISTRY XPT manufactured by Siemens Healthcare Diagnostics Inc..
[78473094]
The customer contacted a siemens customer care center (ccc) specialist regarding the discordant, falsely low direct hdl cholesterol results. The siemens ccc specialist remotely confirmed that the initial discordant results were not flagged by the instrument as being below the assay range. However, the laboratory information system (lis) automatically ordered a re-run of the samples and the repeat results were considered to be correct. There are no reports of any other discordant direct hdl cholesterol results from this system and the customer has not encountered this issue since. The cause of the discordant, falsely low direct hdl cholesterol results 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
[78473095]
Discordant, falsely low direct hdl (high density lipoprotein) cholesterol results were obtained on multiple patient samples on an advia chemistry xpt instrument. The initial results were not reported to physician(s). The same samples were repeated on the same instrument and higher results for direct hdl cholesterol were obtained. The repeat results were in alignment with the physiological profile of the patients. The repeat results were reported to physician(s). There are no known reports of patient intervention due to the discordant, falsely low direct hdl cholesterol results. There are no known reports of a delay in administering treatment or medical intervention to patients due to the discordant, falsely low direct hdl cholesterol results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00398 |
| MDR Report Key | 6669766 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-27 |
| Date of Report | 2017-08-08 |
| Date of Event | 2017-05-31 |
| Date Mfgr Received | 2017-07-25 |
| Date Added to Maude | 2017-06-27 |
| 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 | DEVYANI CHAUDHURI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242637 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION # 3003637681 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO, 96-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 96-8558 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY XPT |
| Generic Name | ADVIA CHEMISTRY XPT ANALYZER |
| Product Code | LBS |
| Date Received | 2017-06-27 |
| Model Number | ADVIA CHEMISTRY XPT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA CHEMISTRY XPT |
| Generic Name | ADVIA CHEMISTRY XPT ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-27 |
| Model Number | ADVIA CHEMISTRY XPT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-27 |