MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-15 for ADVIA CENTAUR XP CORTISOL (COR) ASSAY N/A 10309078 manufactured by Siemens Healthcare Diagnostics, Inc..
[62804051]
The cause for the falsely elevated advia centaur xp cortisol patient result is unknown. Siemens is investigating the incident. The instruction for use under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. "
Patient Sequence No: 1, Text Type: N, H10
[62804054]
Falsely elevated advia centaur xp cortisol patient results were reported by the customer, and considered discordant compared to the lower alternate cortisol test method results. The advia centaur xp cortisol result indicated an adequate response to synacthen stimulation, and there was a delay in the patient receiving hydrocortisone replacement treatment. There was no report of adverse health consequences due to the discordant advia centaur xp cortisol result or delayed treatment.
Patient Sequence No: 1, Text Type: D, B5
[68217711]
Siemens filed the initial mdr 1219913-2016-00245 on 12/02/2016 for falsely elevated advia centaur xp cortisol patient results. 01/26/2017 - additional information: the patient was not taking any medication prior to testing, and has subsequently been started on hydrocortisone. The patient samples were collected on (b)(6) 2016, referred to another laboratory for 17-hydroxyprogesterone analysis, and cortisol was inadvertently measured on each sample. Based on the difference of the cortisol results between the advia centaur xp and the alternate test method (#1), the samples were sent out to another laboratory test method (#2) for further confirmation. Note: the cortisol results from alternate test method (#1), and alternate test method (#2) were reported in mdr 1219913-2016-00245. Baseline patient results prior to the synacthen test. Time (minutes): 0 , 30, 60; cortisol results (nmol/l): 254, 453, 470. Other laboratory findings: urine steroid profile has confirmed 11-hydroxylase deficiency (incomplete as cortisol metabolites are present too). Siemens continues to investigate.
Patient Sequence No: 1, Text Type: N, H10
[75950302]
Siemens filed the initial mdr 1219913-2016-00245 on 12/02/2016 for falsely elevated advia centaur xp cortisol patient result and mdr 1219913-2016-00245 supplemental report 1 filed on 02/07/2017 for additional information. On 04/26/2017 - additional information: based on confirmed 11- hydroxylase deficiency, there is sufficient literature that documents that a consequence of the lack of 11-hydroxylase activity leads to the accumulation of metabolic intermediates like 11-deoxycortisol, which is listed in the instruction for use (ifu) as a potentially cross-reactive substance in the advia centaur xp cortisol assay. It is therefore very likely that the discordant results, with the roche cobas gen ii assay, and the lc/ms-ms are due to cross-reactivity due to accumulation of 11-deoxy-cortisol. The instruction for use under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " the instrument is performing within specifications. No further device evaluation is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2016-00245 |
| MDR Report Key | 6177254 |
| Date Received | 2016-12-15 |
| Date of Report | 2017-05-16 |
| Date of Event | 2016-11-09 |
| Date Mfgr Received | 2017-04-26 |
| Device Manufacturer Date | 2016-04-07 |
| Date Added to Maude | 2016-12-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP CORTISOL (COR) ASSAY |
| Generic Name | CORTISOL IMMUNOASSAY |
| Product Code | JFT |
| Date Received | 2016-12-15 |
| Model Number | N/A |
| Catalog Number | 10309078 |
| Lot Number | 019308 |
| Device Expiration Date | 2017-07-07 |
| 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 | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-15 |