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 2018-03-28 for ADVIA CENTAUR CP manufactured by Siemens Healthcare Diagnostics Inc..
[103950686]
A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the instrument, the cse replaced the acid and base pump and sample syringe, cleaned the wash station and luminometer, checked the acid, base, reagent, and sample dispenses, and calibrated the sample and reagent probes. A siemens regional support center specialist reviewed the instrument data, which was indicative that either there was no sample in the cuvette or there was no acid/base solution to create a reaction. The cause of the discordant psa result on one patient sample is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[103950687]
A discordant prostate specific antigen (psa) result was obtained on one patient sample on an advia centaur cp instrument. The customer stated that the initial result was normal. The sample was repeated on the same instrument as the patient had a history of prostate disease. The sample was repeated on an unknown instrument and a different value was obtained. It is unknown which result was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant psa result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00132 |
| MDR Report Key | 7379720 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-28 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2018-03-23 |
| Date Added to Maude | 2018-03-28 |
| 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 | SHWETA GULATI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242870 |
| Manufacturer G1 | STRATEC BIOMEDICAL AG |
| Manufacturer Street | REGISTRATION #: 8043379 GEWERBESTRASSE 37 |
| Manufacturer City | BIRKENFELD, GRAEFENHAUSEN 75217 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75217 |
| 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 | LTJ |
| Date Received | 2018-03-28 |
| Model Number | ADVIA CENTAUR CP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-03-28 |
| 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 | 2018-03-28 |