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 2017-03-09 for ADVIA CENTAUR CP manufactured by Siemens Healthcare Diagnostics Inc..
[69566358]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse checked and verified functioning of the system fluidic, wash 1 and acid and base. The cse found that the wash 1 pump was cracked and replaced it. The cse rerouted the tubings, cleaned luminometer and checked dark count, which was acceptable. The cse then replaced the sample probe and performed sample and reagent probe alignment. The cse ran calibration and quality controls, which were acceptable. During a follow-up visit, the cse checked the instrument setting and set up the correct ratio factor. The cse ran the random urine samples and survey samples on the advia centaur cp and advia centaur xp instruments, which matched. A siemens headquarters support center (hsc) specialist reviewed the service report. The hsc specialist stated that the factor application for cortisol is required to adjust for matrix differences between calibrators and urine samples. The cause of the incorrect cortisol results being reported was due to the ratio factor not being set prior to reporting of the patient results. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[69566359]
The customer processed the patient samples for cortisol assay on an advia centaur cp instrument. The factor application was not applied to the 24 hour urine cortisol results prior to reporting the results to the physician(s). The physician(s) questioned the incorrect results. The customer applied a correct factor application and reported the correct results to the physician(s). There are no reports of patient intervention or adverse health consequences due to the incorrect cortisol results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00143 |
| MDR Report Key | 6393762 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-09 |
| Date of Report | 2017-03-09 |
| Date of Event | 2016-11-17 |
| Date Mfgr Received | 2016-11-17 |
| Date Added to Maude | 2017-03-09 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | STRATEC BIOMEDICAL AG |
| Manufacturer Street | REGISTRATION #: 8043379 GEWERBESTRASSE 37 |
| Manufacturer City | BIRKENFELD, GRAEFENHAUSEN 75217 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75217 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR CP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JFT |
| Date Received | 2017-03-09 |
| Model Number | ADVIA CENTAUR CP |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA CENTAUR CP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-09 |
| Model Number | ADVIA CENTAUR CP |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-09 |