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 2017-03-17 for ADVIA CENTAUR CP manufactured by Siemens Healthcare Diagnostics Inc..
[70340757]
The customer contacted a siemens customer care center (ccc) specialist. The customer stated their technician performed daily maintenance during the night shift and forgot to reconnect the water line to the water bottle, leaving the tubing connected to the cleaning bottle. The customer reviewed their quality control (cq) in the morning and found to be out of range. The customer performed cleaning multiple times with just water. The customer performed an automated system prime multiple times. The customer performed qc, resulting within range. The cause of the discordant, discordant, depressed and elevated b-type natriuretic peptide results is due user error. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[70340758]
Discordant, falsely depressed and elevated b-type natriuretic peptide results were obtained and reported out when quality control was out of range on two patient samples on an advia centaur cp instrument. The initial results were reported out to the physician(s). The same samples were repeated on the same advia centaur cp instrument, resulting within the patient's expected clinical range. The customer issued corrected reports to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, depressed and elevated b-type natriuretic peptide results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00196 |
| MDR Report Key | 6415389 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-17 |
| Date of Report | 2017-03-17 |
| Date of Event | 2017-02-20 |
| Date Mfgr Received | 2017-02-20 |
| Date Added to Maude | 2017-03-17 |
| 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 | 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 | NBC |
| Date Received | 2017-03-17 |
| 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 | 2017-03-17 |
| 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 AVE. TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-17 |