MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-02-17 for ADVIA CENTAUR XP SYPHILIS (SYPH) ASSAY N/A 10492493 manufactured by Siemens Healthcare Diagnostics, Inc..
[5360439]
(b)(6) advia centaur xp syphilis (syph) results were obtained for a patient sample during validation. One patient sample was tested on the rpr method and the result was reactive. The patient sample was tested on the fta-abs blood test (confirmatory test). The test resulted as reactive minimal. Patient treatment was not altered or prescribed. There was no report of adverse health consequences due to the (b)(6) advia centaur xp syphilis results.
Patient Sequence No: 1, Text Type: D, B5
[12829897]
The cause for the (b)(6) syphilis (syph) results is unknown. The instrument is performing within specifications. No further evaluation of the device is required. The ifu states in the limitations section: "a nonreactive test result does not exclude the possibility of exposure to or infection with (b)(6) antibodies may be undetectable in some stages of the infection and in some clinical conditions. "
Patient Sequence No: 1, Text Type: N, H10
[38829741]
Siemens filed the initial mdr 1219913-2015-00031 on february 17, 2015. On 04/28/2015 additional information: the customer sent the patient sample to siemens healthcare diagnostics for further testing and investigation. However, the sample was received thawed. The sample was sent on gel packs instead of frozen on dry ice as per protocol. The patient sample was run on three lots of the adiva centaur (b)(6) reagent. The lot numbers were 128018, 128019, and 128021. The results were negative across the lots. This is the same observation as the customer. (b)(6) results (index): lot 128018: 0. 15, lot 128019: 0. 11, lot 128021: 0. 07. Siemens was unable to determine the cause of the discordant results. The patient sample was not considered valid since the sample was received thawed. Historical information for the sample was not available. No further evaluation of the device is required. The ifu states in the specimen collection and handling section: "-freeze samples, devoid of red blood cells, at or below -20? C for longer storage. Do not store in a frost-free freezer. Thoroughly mix thawed samples and centrifuge before using. When 10 samples were subject to 6 freeze/thaw cycles, no clinically significant differences were observed. -package and label samples for shipment in compliance with applicable federal and international regulations covering the transport of clinical samples and etiological agents. Store samples stoppered at 2-8 degrees celsius upon arrival. If shipment is expected to exceed 7 days, ship specimens frozen. Samples maintained at room temperature up to 7 days or refrigerated up to 7 days demonstrated no qualitative differences. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2015-00031 |
| MDR Report Key | 4521030 |
| Report Source | 05,06,07 |
| Date Received | 2015-02-17 |
| Date of Report | 2015-01-30 |
| Date of Event | 2015-01-23 |
| Date Mfgr Received | 2015-04-28 |
| Device Manufacturer Date | 2014-01-27 |
| Date Added to Maude | 2015-03-19 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP SYPHILIS (SYPH) ASSAY |
| Generic Name | SYPHILIS ASSAY |
| Product Code | LIP |
| Date Received | 2015-02-17 |
| Model Number | N/A |
| Catalog Number | 10492493 |
| Lot Number | 128021 |
| ID Number | N/A |
| Device Expiration Date | 2015-12-15 |
| 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 | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-17 |