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 2016-05-20 for ADVIA CENTAUR CP manufactured by Siemens Healthcare Diagnostics Inc..
[45627892]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse replaced tubes from the peristaltic pump 3 and both rinsing block assemblies. The cse then cleaned the luminometer. The cse checked the reagent and sample probes' position and dispense volume of acid and base. The cause of the discordant sex hormone-binding globulin (shbg) result is unknown. Siemens is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[45627893]
A discordant sex hormone-binding globulin (shbg) patient result was obtained on an advia centaur cp instrument. The discordant result was not reported to the physician(s). The sample was repeated on the same advia centaur cp instrument. There are no known reports of patient intervention or adverse health consequences due to the discordant shbg result.
Patient Sequence No: 1, Text Type: D, B5
[54714442]
The initial mdr 2432235-2016-00255 was filed on may 20, 2016. Additional information was received on 07/26/2016: no other discordant results occurred on the system since customer service engineer (cse) was at the customer's site. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00255 |
| MDR Report Key | 5669843 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-20 |
| Date of Report | 2016-07-29 |
| Date of Event | 2016-04-21 |
| Date Mfgr Received | 2016-07-26 |
| Device Manufacturer Date | 2009-05-20 |
| Date Added to Maude | 2016-05-20 |
| 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 | MRS. MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | STRATEC BIOMEDICAL SWITZERLAND AG |
| Manufacturer Street | REGISTRATION #: 3008494306 GEWERBESTRASSE 6 |
| Manufacturer City | NEUHAUSEN AM RHEINFALL, 8212 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR CP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | CDZ |
| Date Received | 2016-05-20 |
| Model Number | ADVIA CENTAUR CP |
| 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 CP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-05-20 |
| Model Number | ADVIA CENTAUR CP |
| 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 | 2016-05-20 |