MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-07-07 for ADVIA CENTAUR CP manufactured by Siemens Healthcare Diagnostics Inc..
[6018866]
Discordant results were obtained on patient samples tested for multiple methods on an advia centaur cp instrument. Discordant results were not reported to the physician(s), as the customer stated that results were not believable. Quality controls were out of range for all methods. It is unknown if repeat testing was performed. There are no reports of patient intervention or adverse health consequences due to the discordant results.
Patient Sequence No: 1, Text Type: D, B5
[14226790]
A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument and instrument data, the cse replaced the wash 1 solution due to contamination and cleaned the luminometer due to base residue. The cause of the discordant 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
| Report Number | 2432235-2015-00318 |
| MDR Report Key | 4894270 |
| Report Source | 05,06 |
| Date Received | 2015-07-07 |
| Date of Report | 2015-06-11 |
| Date of Event | 2015-06-11 |
| Date Mfgr Received | 2015-06-11 |
| Date Added to Maude | 2015-08-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | STRATEC BIOMEDICAL SWITZERLAND AG |
| Manufacturer Street | REGISTRATION #: 3008494306 NEUWIESENSTRASSE 4 |
| Manufacturer City | BERINGEN, 8222 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8222 |
| 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 | MOI |
| Date Received | 2015-07-07 |
| Model Number | ADVIA CENTAUR CP |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-07 |