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 2017-01-31 for ADVIA CENTAUR CP manufactured by Siemens Healthcare Diagnostics Inc..
[66220151]
The customer contacted the siemens customer care center (ccc). The quality controls (qc) results were higher than the mean values. The ccc specialist reviewed event log and found no issues with sample integrity nor aspiration errors. The siemens customer service engineer (cse) was dispatched to the customer site. The cse performed a total service call. The cse recalibrated the sample probe to tip tray housing. The cse performed qc, which were within range. A siemens headquarter support center (hsc) reviewed the service activity related to this event and discovered that the bnp assay uses a 100? L sample volume. A result of 0. 00 pg/ml indicated that either sample was not dispensed or acid/base reagent was not dispensed. The cause of the discordant, falsely depressed bnp result on one patient sample 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
[66220152]
A discordant, falsely depressed brain natriuretic peptide (bnp) result was obtained on a patient sample on an advia centaur cp instrument. The discordant bnp result was not reported to the physician(s). The sample was repeated in duplicate on the same advia centaur cp instrument, resulting higher. The corrected result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed bnp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00093 |
| MDR Report Key | 6290348 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-31 |
| Date of Report | 2017-01-31 |
| Date of Event | 2017-01-09 |
| Date Mfgr Received | 2017-01-09 |
| Date Added to Maude | 2017-01-31 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | NBC |
| Date Received | 2017-01-31 |
| Model Number | ADVIA CENTAUR CP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-01-31 |
| Model Number | ADVIA CENTAUR CP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-01-31 |