MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-04-23 for ADVIA CENTAUR PROGESTERONE (PRGE) N/A 02382928 manufactured by Siemens Healthcare Diagnostics, Inc..
[3272494]
A falsely elevated advia centaur progesterone result was obtained by the customer on a patient sample and considered discordant when compared to lower results when repeated on a new reagent lot. The customer noted an out or range quality control level three result and observed that the reagent pack was grainy in appearance. The discordant sample was repeated on a new reagent lot and the results were reproducible. There was no report of adverse health consequences due to the discordant high advia centaur progesterone result.
Patient Sequence No: 1, Text Type: D, B5
[10715380]
The cause for the initially discordant high patient result and out of range quality control level three result is unknown. The customer observed that the reagent pack was grainy in appearance and at the time of the issue and may be a contributing factor. A new progesterone reagent lot was replaced and the customer observed acceptable quality control and patient results. There have been no other reported customer complaints of progesterone reagent packs with a grainy appearance for lot 259. No conclusion can be drawn. The instruction for use (ifu) states the following under the loading reagents section: "ensure that the system has sufficient primary and ancillary reagent packs. For detailed information about preparing the system, refer to the system operating instructions or to the online help system. Caution: mix all primary reagent packs by hand before loading them onto the system. Visually inspect the bottom of the reagent pack to ensure that all particles are dispersed and resuspended. " the instruction for use (ifu) states the following under the quality control section: "siemens healthcare diagnostics recommends the use of commercially available quality control materials with at least 2 levels (low and high). A satisfactory level of performance is achieved when the analyte values obtained are within the acceptable control range for the system or within your range, as determined by an appropriate internal laboratory quality control scheme. If the quality control results do not fall within the expected values or within the laboratory's established values, do not report results. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2013-00074 |
| MDR Report Key | 3073621 |
| Report Source | 05,06 |
| Date Received | 2013-04-23 |
| Date of Report | 2012-07-07 |
| Date of Event | 2012-07-06 |
| Date Mfgr Received | 2012-07-07 |
| Date Added to Maude | 2013-06-26 |
| 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 | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY ST. |
| Manufacturer City | EAST 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 | EAST 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 PROGESTERONE (PRGE) |
| Generic Name | PROGESTERONE |
| Product Code | JLS |
| Date Received | 2013-04-23 |
| Model Number | N/A |
| Catalog Number | 02382928 |
| Lot Number | 259 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-04-23 |