MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-05-28 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[5893525]
Intact parathyroid hormone (ipth) testing was delayed for one intraoperative patient. The patient was undergoing parathyroid surgery. The operator could not run the patient sample on an advia centaur xp instrument due to a software crash. After reboot, it took an additional 40 minutes until the system was ready to run the patient sample. Thus the surgery took an additional 90 minutes to complete due to the delay in obtaining ipth testing results. There are no known reports of patient intervention or adverse health consequences due to delay in testing the ipth patient sample.
Patient Sequence No: 1, Text Type: D, B5
[13409218]
The customer contacted a siemens customer care center (ccc) specialist. The customer stated that they were having issues with the turn disc at the external sample position of the system, which generated a lot of error messages. During this time, the customer loaded the sample for the measurement of ipth on the system and experienced a software crash. The customer rebooted the system and ran the patient sample. As a preventive measure, the customer has changed their standard operating procedure. In the future, before an intraoperative sample is run in frontload, the system must be disconnected from automation. The cause of delay in testing the ipth result was related to the software crash. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[32158736]
The initial mdr 2432235-2015-00269 was filed on may 28, 2015. Additional information (05/06/2015): use of the advia centaur intact parathyroid hormone (ipth) assay on intraoperative samples is off-label use. As per the instructions for use for advia centaur ipth, this assay is for in vitro diagnostic use in the quantitative determination of ipth in edta plasma or serum using the advia centaur, advia centaur xp, and advia centaur xpt systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.
Patient Sequence No: 1, Text Type: N, H10
[32604152]
The initial mdr 2432235-2015-00269 was filed on may 28, 2015. The first supplemental mdr 2432235-2015-00269_s1 was filed on may 29, 2015. Additional information (08/07/2015): in addition to the off-label use noted in supplemental report #1, the following was found related to the instrument. A siemens headquarters support center (hsc) specialist reviewed the instrument data and indicated that there is no evidence that the cause was related to a software crash. The hsc specialist stated that one of the samples had three tests associated with it and was repeatedly processed 55 times causing the front loaded ipth sample not to run. The ipth sample was eventually rescheduled and the result was obtained. The cause of delay in testing the ipth result on one patient sample is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00269 |
| MDR Report Key | 4803508 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-05-28 |
| Date of Report | 2015-05-06 |
| Date of Event | 2015-04-24 |
| Date Mfgr Received | 2015-08-07 |
| Device Manufacturer Date | 2011-01-10 |
| Date Added to Maude | 2015-06-24 |
| 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 | MICHAEL METZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED REGISTRATION NUMBER: 8020888 |
| Manufacturer City | CHAPEL LANE, SWORDS, CO., DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | MOI |
| Date Received | 2015-05-28 |
| Model Number | ADVIA CENTAUR XP |
| 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 | 2015-05-28 |