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 2016-12-09 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[62383246]
The customer contacted the siemens customer care center (ccc) and stated that the sample was processed while the quality controls (qc) were out of range. The customer was in the middle of recalibrating the assay when the patient sample was processed. The customer performed calibrations and reran qc, which were within range. The cause of the discordant, falsely elevated sal result on a patient sample was due to operator processing the sample with invalid qc. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[62383247]
A discordant, falsely elevated salicylate (sal) result was obtained on a patient sample on the advia 1800 instrument. The discordant result was reported to the physician(s). The sample was repeated on the same instrument, resulting lower. The corrected result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated sal result.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2432235-2016-00761 |
MDR Report Key | 6159010 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2016-12-09 |
Date of Report | 2016-12-09 |
Date of Event | 2016-11-15 |
Date Mfgr Received | 2016-11-15 |
Date Added to Maude | 2016-12-09 |
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. (REGISTRATION # 3003637681) |
Manufacturer Street | 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 1800 |
Generic Name | CLINICAL CHEMISTRY ANALYZER |
Product Code | DKJ |
Date Received | 2016-12-09 |
Model Number | ADVIA 1800 |
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 AVENUE TARRYTOWN NY 10591 US 10591 |
Brand Name | ADVIA 1800 |
Generic Name | CLINICAL CHEMISTRY ANALYZER |
Product Code | JJE |
Date Received | 2016-12-09 |
Model Number | ADVIA 1800 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
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 | 2016-12-09 |