MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-08-19 for ADVIA CENTAUR XP DIGOXIN (DIG) N/A 05207094 manufactured by Siemens Healthcare Diagnostics, Inc..
[3830510]
An elevated advia centaur xp digoxin result was obtained for a patient sample and reported to the physician. The patient was admitted to the hospital. Two samples were taken during admission and tested on alternate method. The results were lower. The initial sample was tested with heterophile blocking tubes on the advia centaur xpand the result was elevated. Aliquots of the initial sample were sent to three other laboratories for testing on alternate methods and the results were lower. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the elevated digoxin result. The patient was discharged after the two samples taken during admission showed normal results and since the patient was asymptomatic.
Patient Sequence No: 1, Text Type: D, B5
[11017126]
The two samples taken during admission were tested using the ultrafiltration test. The advia centaur xp digoxin result prior to ultrafiltration was 5. 7 nmol/l and the result on the ultrafiltrate was 0. 46 nmol/l which could indicate that there are either exogenous or endogenous digoxin like immunoreactive substance (dlifs) in the sample. A control sample was also tested before and after ultrafiltration. The advia centaur xp digoxin result before ultrafiltration was 3. 6 nmol/l and after ultrafiltration was 2. 6 nmol/l. The cause for the elevated advia centaur xp digoxin results when compared to the lower test results from the alternate test methods is possible interference. The patient sample has been requested for further investigation. The calibration and qc was acceptable. The instrument is performing within specification. The ifu states in the limitations section: "digibind drug therapy affects digoxin immunoassay results. Interpret digoxin results from patients who have been administered digibind with caution. Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed. Additional information may be required for diagnosis. "
Patient Sequence No: 1, Text Type: N, H10
[34652437]
Siemens filed the initial mdr on (b)(6) 2013. On (b)(6) 2013: additional information: siemens has reviewed the list of medications taken by the patient against the instructions for use (ifu). None of the medications from the list were identified in the ifu except for spironolactone. As indicated in the instructions for use in the performance characteristics section, spironolactone was tested and did not have a significant effect on digoxin measurement. The ultrafiltration test would be expected to remove the interference. However, the test would not identify the interferent. The investigation to identify the possible interfering substance in the patient sample will not be pursued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2013-00181 |
| MDR Report Key | 3296234 |
| Report Source | 05,06 |
| Date Received | 2013-08-19 |
| Date of Report | 2013-07-25 |
| Date of Event | 2013-07-22 |
| Date Mfgr Received | 2013-08-26 |
| Date Added to Maude | 2013-11-13 |
| 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 XP DIGOXIN (DIG) |
| Generic Name | DIGOXIN IMMUNOASSAY |
| Product Code | KXT |
| Date Received | 2013-08-19 |
| Model Number | N/A |
| Catalog Number | 05207094 |
| Lot Number | 208 |
| ID Number | N/A |
| Device Expiration Date | 2014-03-12 |
| 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 | 2013-08-19 |