MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-11-12 for ADVIA CENTAUR PROGESTERONE (PRGE) ASSAY N/A 02382928 manufactured by Siemens Healthcare Diagnostics, Inc..
[20332550]
Imprecise advia centaur progesterone results were obtained for patient samples. The imprecision was noticed after failure of the external quality control (qc). The customer noticed fliers on their internal qc. Patient samples were run in duplicate. It is unknown if patient treatment was prescribed or altered. There was no report of adverse health consequences due to the imprecise progesterone results.
Patient Sequence No: 1, Text Type: D, B5
[20557013]
The cause for the discordant progesterone results is unknown. Siemens healthcare diagnostics, inc. Is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[34899189]
Siemens filed the initial mdr on november 12, 2013. On 02/14/2014 additional information: siemens conducted a precision investigation in november 2013. The investigation concluded that the advia centaur progesterone reagent lot #s 262 and 263 both met precision release specifications. However, a higher level of imprecision was observed with reagent lot # 262. The precision investigation conducted by siemens was comprehensive. In addition to testing lot#s 262 and 263 reagents internally, a biostatistician analyzed the data generated at a reference laboratory and reviewed parameters from the manufacturing database including curve shape/fit and rlu precision and dose precision across multiple reagent lots going back two years. There were no manufacturing parameters or raw materials identified for lot# 262 and 263 as different from previous lot numbers and that could explain the increased imprecision observed by customers. The investigation has determined that lot#s 261, 262 and 263 are meeting precision specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2013-00278 |
| MDR Report Key | 3463191 |
| Report Source | 05,06 |
| Date Received | 2013-11-12 |
| Date of Report | 2013-10-18 |
| Date of Event | 2013-10-01 |
| Date Mfgr Received | 2014-01-24 |
| Date Added to Maude | 2014-02-07 |
| 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 | 0 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR PROGESTERONE (PRGE) ASSAY |
| Generic Name | PROGESTERONE IMMUNOASSSAY |
| Product Code | JLS |
| Date Received | 2013-11-12 |
| Model Number | N/A |
| Catalog Number | 02382928 |
| Lot Number | 059262 |
| ID Number | N/A |
| Device Expiration Date | 2014-04-06 |
| 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 | 2013-11-12 |