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 2016-02-29 for ADVIA CENTAUR XP CYCLOSPORINE (CSA) ASSAY N/A 10335448 manufactured by Siemens Healthcare Diagnostics, Inc..
[39312085]
The cause for the discordant advia centaur xp cyclosporine (csa) results is unknown. There was no sample material left for dilution experiments. A new sample from the patient is currently being tested with the alternate method. The results from this sample will be provided to siemens once it is available. Siemens healthcare diagnostics is investigating. The instrument is performing within specifications. The ifu states in the limitations section: "always use measurements of csa in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation. "
Patient Sequence No: 1, Text Type: N, H10
[39312086]
Low advia centaur xp cyclosporine (csa) results were obtained on samples from two patients during a method comparison. The cyclosporine results were 50% lower than the alternate method. The alternate method results are considered to reflect a better clinical picture. It is unknown if patient treatment was prescribed or altered. There was no report of adverse health consequences due to the discordant cyclosporine (csa) results.
Patient Sequence No: 1, Text Type: D, B5
[41632434]
Siemens filed the initial mdr 1219913-2016-00048 on february 29, 2016. On 03/22/2016: additional information: one of the patient's age was provided: (b)(6). Siemens healthcare diagnostics is investigating.
Patient Sequence No: 1, Text Type: N, H10
[45290217]
On 04/19/2016: additional information:the lot number used was 108023. Expiration date 01/28/2017. Manufacture date: 01/28/2015. Siemens healthcare diagnostics is investigating.
Patient Sequence No: 1, Text Type: N, H10
[47760674]
Siemens filed the initial mdr 1219913-2016-00048 on february 29, 2016. Siemens filed the mdr 1219913-2016-00048 supplemental report 1 on march 31, 2016. On 03/312016: additional information: additional samples from the two patients were tested on the advia centgaur xp and an alternate method. Patient 1 sample results: advia centaur xp: 71. 11 ug/l, alternate method: 80 ug/l, the above comparison data was acceptable to the customer. Patient 2 sample results: advia centaur xp: 67. 73 and 61. 65ug/l, alternate method: 80 ug/l. The above comparison data was unacceptable to the customer. The customer explains that only this patient differs when compared with an alternate method. The customer suspects an interfering factor in this patient sample or a different metabolism for this patient. Siemens healthcare diagnostics is investigating.
Patient Sequence No: 1, Text Type: N, H10
[48199093]
Siemens filed the initial mdr 1219913-2016-00048 on february 29, 2016. Siemens filed the mdr 1219913-2016-00048 supplemental report 1 on march 31, 2016. Siemens filed the mdr 1219913-2016-00048 supplemental report 2 on april 19, 2016. Siemens filed the mdr 1219913-2016-00048 supplemental report 3 on may 16, 2016. On 06/14/2016: additional information: siemens received two patient samples. The patient samples were tested on the advia centaur and dimension vista cyclosporine assays. The samples were run both neat and diluted. Cyclosporine results (ng/ml): sample 1 (purple top), advia centaur, dimension: neat, 64. 08, 89. 5; 1:2, 18. 44, n/a; 1:4, 7. 23, n/a. Sample 2 (lavender top): neat, 57. 58, 89. 5; 1:2, 6. 09, n/a; 1:4, 0. 0, n/a. The dilution results indicate there could be an interferent with the samples that impact the patient results. The cause for the discordant advia centaur xp cyclosporine (csa) results is unknown. Possible interferent that can not be determined based on the information and data provided. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2016-00048 |
| MDR Report Key | 5467480 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-29 |
| Date of Report | 2016-06-17 |
| Date of Event | 2015-12-22 |
| Date Mfgr Received | 2016-06-14 |
| Device Manufacturer Date | 2015-06-09 |
| Date Added to Maude | 2016-02-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP CYCLOSPORINE (CSA) ASSAY |
| Generic Name | CYCLOSPORINE |
| Product Code | MKW |
| Date Received | 2016-02-29 |
| Model Number | N/A |
| Catalog Number | 10335448 |
| Lot Number | UNKNOWN |
| 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 AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-29 |