MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-22 for ADVIA CENTAUR FERRITIN (FER) ASSAY N/A 00495776 manufactured by Siemens Healthcare Diagnostics, Inc..
[3672420]
Discordant advia centaur ferritin results were obtained on six samples from the same patient. Patient history is hemophagocytic lymphohistiocytosis (hlh). The patient samples were tested within 6 days and were all fresh draws. Repeat testing was performed on the samples and the results were all high. It is unknown if patient treatment was prescribed or altered. There was no report of adverse health consequences due to the discordant ferritin results.
Patient Sequence No: 1, Text Type: D, B5
[11001788]
The cause for the discordant ferritin results is unknown. The hook effect is a possible cause. The instrument is performing within specifications. No further evaluation of the device is required. The ifu states in the high dose hook effect section: "patient samples with high ferritin levels can cause a paradoxical decrease in the rlus (high dose hook effect). In this assay, patient samples with ferritin levels as high as 80,000 ng/ml (176,000 pmol/l) will assay greater than 1650 ng/ml (3630 pmol/l). " the ifu states in the dilutions section: "samples with ferritin levels greater than 1650 ng/ml (3630 pmol/l) must be diluted and retested to obtain accurate results. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2013-00152 |
| MDR Report Key | 3240930 |
| Report Source | 05,06 |
| Date Received | 2013-07-22 |
| Date of Report | 2013-06-23 |
| Date of Event | 2013-06-18 |
| Date Mfgr Received | 2013-06-23 |
| Date Added to Maude | 2013-10-17 |
| 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 FERRITIN (FER) ASSAY |
| Generic Name | FERRITIN IMMUNOASSAY |
| Product Code | DBF |
| Date Received | 2013-07-22 |
| Model Number | N/A |
| Catalog Number | 00495776 |
| Lot Number | 230 |
| ID Number | N/A |
| Device Expiration Date | 2013-11-06 |
| 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 | 2013-07-22 |