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 2017-04-25 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[73670709]
The customer contacted a siemens customer care center (ccc) specialist. The customer stated that a customer questioned a result that was sent out. The customer tested a re-drawn sample from that patient, resulting higher. The customer performed a lookback and repeated all low testosterone results. The customer front loaded the samples and most repeated higher. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse inspected the instrument. The cse found the sample probe vertical printed circuit board (pcb) cable and acid pump was found to be worn. The sample probe vertical sensor cable was replaced and the probe assembly was inspected, with no issues found. The cse replaced the acid pump. The cse ran quality control (qc), resulting within range. The cause of the discordant, falsely depressed testosterone results 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
[73670710]
Discordant, falsely depressed testosterone results were obtained on twelve patient samples on an advia centaur xp instrument. The initial results were not reported out to the physician(s). The customer repeated the same sample on the same advia centaur xp instrument resulting higher. The customer reported out the repeat results to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed testosterone results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00289 |
| MDR Report Key | 6521154 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-25 |
| Date of Report | 2017-04-25 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2017-03-30 |
| Device Manufacturer Date | 2014-10-13 |
| Date Added to Maude | 2017-04-25 |
| 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 | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD |
| 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 | IMMUNOASSAY ANALYZER |
| Product Code | CDZ |
| Date Received | 2017-04-25 |
| 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 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-25 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-04-25 |