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 2016-05-27 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[46165092]
The customer contacted the siemens customer care center (ccc). The customer is concerned with qc variation, which results lower in the morning than the afternoon run. Qc resulted within range on the day of event. The ccc dispatched a customer service engineer (cse) to the customer site. The cse inspected the instrument and found a leaking base pump and replaced it. Quality control (qc) was tested and was in range. The cse requested the customer to run calibration and then run qc five times. The customer performed a parallel study between two lots, and the results were within acceptable ranges. The cause of the discordant testosterone results is unknown. The system performed as intended. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[46165093]
Discordant, testosterone results were obtained on patient samples on an advia centaur xp instrument. The discordant results were reported out to the physician(s). The results were questioned by the physician. The samples were repeated twice, on two different days, on the same advia centaur xp instrument. Corrected reports were not issued. The customer was not confident with repeat results obtained due to shifts quality control (qc) recovery. There are no known reports of patient intervention or adverse health consequences due to the discordant, testosterone patient results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00272 |
| MDR Report Key | 5686435 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-27 |
| Date of Report | 2016-05-27 |
| Date of Event | 2016-04-27 |
| Date Mfgr Received | 2016-05-03 |
| Device Manufacturer Date | 2009-07-20 |
| Date Added to Maude | 2016-05-27 |
| 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 | MRS. MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMIT |
| Manufacturer Street | REGISTRATION NUMBER: 8020888 CHAPEL LANE |
| Manufacturer City | 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDZ |
| Date Received | 2016-05-27 |
| Model Number | ADVIA CENTAUR XP |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-27 |