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 2017-03-31 for ADVIA CHEMISTRY XPT manufactured by Siemens Healthcare Diagnostics Inc..
[71484210]
The customer contacted a siemens customer care center (ccc). The customer stated that calibrations and quality controls for chol were within acceptable range. The cause of the discordant, falsely low chol result on one patient sample is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[71484211]
A discordant, falsely low cholesterol (chol) result was obtained on one patient sample on an advia chemistry xpt instrument. The discordant result was reported to the physician(s), who questioned it. The sample was repeated twice on the same instrument, resulting higher both times and matching the clinical picture of the patient. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low chol result.
Patient Sequence No: 1, Text Type: D, B5
[78172180]
The initial mdr 2432235-2017-00217 was filed on march 31, 2017. Additional information (05/11/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided by the customer. The customer had recalibrated the assay prior to performing a second repeat run for cholesterol and obtaining a result of 244 mg/dl. The hsc specialist stated that recalibrating alone may not have resolved the issue as all samples and quality controls would be affected by a calibration issue. The hsc specialist concluded that the issue may have been caused due to a sample related issue, such as inadequate sample handling or random error. The cause of the discordant, falsely low cholesterol result on one patient sample is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2017-00217 |
| MDR Report Key | 6450010 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-31 |
| Date of Report | 2017-05-31 |
| Date of Event | 2017-02-24 |
| Date Mfgr Received | 2017-05-11 |
| Device Manufacturer Date | 2015-08-17 |
| Date Added to Maude | 2017-03-31 |
| 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 AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION NUMBER: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 | CHH |
| Date Received | 2017-03-31 |
| 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 | 2017-03-31 |
| 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 | 2017-03-31 |