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 2016-06-27 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[48307783]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. The cse checked the sample syringe and sample probe tubing and lubricated the sample syringe. The cse verified the functioning of sample probe to cuvette bottom and reagent 1, reagent 2 and ancillary probes. The cse also verified washing and it was functioning properly. The cse then checked the ancillary diluter, acid and base dispensing and reagent for clumps prior to loading it onto the system. The cse performed precision testing and ran quality controls, which were acceptable. The cause of the discordant testosterone results on multiple patient samples is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[48307784]
Discordant testosterone results were obtained on multiple patient samples on an advia centaur xp instrument. The samples were repeated and the results were different than the initial results. It is unknown if the samples were repeated on the same instrument or on an alternate instrument. It is unknown which results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant testosterone results.
Patient Sequence No: 1, Text Type: D, B5
[49675560]
The initial mdr 2432235-2016-00339 was filed on june 27, 2016. Additional information (07/05/2016): the initial mdr states that it is unknown which results were reported to the physician(s). Additional information that the repeat results were reported to the physician(s) was obtained. The customer also stated that there was delay in reporting of patient results as the samples had to be repeated.
Patient Sequence No: 1, Text Type: N, H10
[49675561]
The discordant results were not reported to the physician(s). The repeat results were reported to the physician(s). Additionally, the customer stated that there was delay in reporting of the results as the patient samples had to be repeated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00339 |
| MDR Report Key | 5750941 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-06-27 |
| Date of Report | 2016-07-07 |
| Date of Event | 2016-05-13 |
| Date Mfgr Received | 2016-07-05 |
| Device Manufacturer Date | 2007-09-03 |
| Date Added to Maude | 2016-06-27 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| 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 | CDZ |
| Date Received | 2016-06-27 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-06-27 |