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 2016-01-25 for ADVIA CENTAUR XP TESTOSTERONE ASSAY N/A 10309989 manufactured by Siemens Healthcare Diagnostics, Inc..
[36822446]
A siemens customer service engineer (cse) was sent to the customer site for system inspection and performed a total service call. The cse replaced the ancillary probe tubing, ancillary probe, and fittings on the fluid manifold. All the probes were aligned and checked. The cse loaded fresh calibrator and reagent for lot 178, performed a reagent lot calibration, ran qc and checked precision. The cause for the discordant advia centaur xp testosterone result during a lot to lot correlation study for reagent lot 177 and lot 178 is unknown. Siemens is investigating.
Patient Sequence No: 1, Text Type: N, H10
[36822447]
Discordant advia centaur xp testosterone results were obtained on samples from three patients during a lot to lot correlation study for reagent lot 177 and lot 178. The results were lower with lot 178. The customer states that the correlation samples were random and testosterone tests were not ordered by the physician(s). The correlation study was repeated with a new reagent readypack (lot 178) and the results were similar. Another new reagent lot 179 was calibrated, the correlation samples retested, and the results were similar to the results obtained initially for reagent lot 178. The quality control (qc) results were within acceptable ranges for all three reagent lots, and the same calibrator lot ce43 was used for each. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant advia centaur xp testosterone correlation results.
Patient Sequence No: 1, Text Type: D, B5
[40346029]
Siemens filed the initial mdr 1219913-2016-00013 on 01/25/2016 for discordant advia centaur xp testosterone results of three patients during a lot to lot correlation study. On 02/19/2016 additional information: the cause for the discordant advia centaur xp testosterone result during a lot to lot correlation study for reagent lot 177 and lot 178 is unknown. A siemens customer service engineer (cse) performed a total service call and did not confirm an instrument issue. The quality control samples tested post service was within acceptable ranges, and the customer is reporting patient results with reagent lot 178, calibrator e, lot ce44 without issue. No conclusion can be drawn. Master curve material (mcm) was provided to the customer for troubleshooting the discordant lot to lot correlation study results. It was observed with calibrator e lot ce43 that mcm level 6 was out low with reagent lots 178 and 179, and mcm level 7 was out low with reagent lot 179. After an internal investigation of calibrator e lot to lot biases which included evaluation of mcm's, siemens distributed an urgent medical device correction cc 16-07. A. Us, and urgent field safety notice cc 16-07. A. Ous on february 04, 2016 informing the customer of a lot to lot bias with calibrator e for the advia centaur testosterone assay. This resolution addresses the mcm low bias observed at the customer site, and it was determined to be unrelated to the discordant lot to lot correlation study results. The instrument is performing within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2016-00013 |
| MDR Report Key | 5389571 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-01-25 |
| Date of Report | 2015-12-31 |
| Date of Event | 2015-12-31 |
| Date Mfgr Received | 2016-02-19 |
| Device Manufacturer Date | 2015-03-31 |
| Date Added to Maude | 2016-01-25 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP TESTOSTERONE ASSAY |
| Generic Name | TESTOSTERONE IMMUNOASSAY |
| Product Code | CDZ |
| Date Received | 2016-01-25 |
| Model Number | N/A |
| Catalog Number | 10309989 |
| Lot Number | 178 |
| Device Expiration Date | 2016-05-31 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-25 |