MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-03-31 for ADVIA CENTAUR XP DIGOXIN (DIG) N/A 05207094 manufactured by Siemens Healthcare Diagnostics, Inc..
[41617299]
The cause for the high advia centaur xp digoxin results is unknown. The digoxin treatment was stopped. Therefore, possible interferent is suspected. Siemens healthcare diagnostics is investigating. 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. The therapeutic range of 0. 80 to 2. 00 ng/ml (1. 02 to 2. 56 nmol/l) includes effective serum concentrations for a wide range of patient populations. Lower concentration of 0. 5 to 1. 2 ng/ml (0. 64 to 1. 54 nmol/l) are more appropriate in certain population such as chronic heart-failure patients. Digoxin toxicity is usually associated with serum levels > 2. 0 ng/ml (2. 6 nmol/l), but it may occur with lower levels. Significant overlap of toxic and nontoxic values has been reported. Consequently, analysis of serum concentration alone is not sufficient for optimization of digoxin therapy. Additional factors such as age, thyroid condition, electrolyte balance, hepatic and renal function, and other clinical symptoms must be considered. "
Patient Sequence No: 1, Text Type: N, H10
[41617300]
False high advia centaur xp digoxin results were obtained for samples from the same patient. The results were always high even if the patient did have the digoxin treatment. The treatment with digoxin was stopped some days before. There was no report of adverse health consequences due to the high digoxin results.
Patient Sequence No: 1, Text Type: D, B5
[43026669]
On 4/07/2016 correction: the second statement in event description is incorrect. The correct statement is: the results were always high even if the digoxin treatment was stopped for the patient. On 04/12/2016 additional information: another sample could not be obtained from the patient. No other information is available regarding the patient's treatment, medications, or medical condition. Therefore, siemens can not evaluate the possible causes for the digoxin discordant result. The cause for the high advia centaur xp digoxin results is unknown. The elevated result appears to be associated with an interferent with the advia centaur digoxin assay. The instrument is performing within specification. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[45772971]
On 05/04/2016 additional information: the customer sent the patient results. (b)(6). The patient doesn't take digoxin now. The patient took only heparin. The field application specialist (fas) exported the following digoxin results: (b)(6). The lot number used was lot 216. Expiration date: 05/22/2016 manufacture date: 05/22/2015. Another sample could not be obtained from the patient. No other information is available regarding the patient's treatment, medications, or medical condition. Therefore, siemens can not evaluate the possible causes for the digoxin discordant result. The cause for the high advia centaur xp digoxin results is unknown. The elevated result appears to be associated with an interferent with the advia centaur digoxin assay. The instrument is performing within specification. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2016-00063 |
| MDR Report Key | 5539853 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-31 |
| Date of Report | 2016-05-24 |
| Date of Event | 2016-03-11 |
| Date Mfgr Received | 2016-05-04 |
| Date Added to Maude | 2016-03-31 |
| 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 | 3 |
| Event Location | 3 |
| 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 DIGOXIN (DIG) |
| Generic Name | DIGOXIN IMMUNOASSAY |
| Product Code | KXT |
| Date Received | 2016-03-31 |
| Model Number | N/A |
| Catalog Number | 05207094 |
| 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 | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-31 |