MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-06 for ADVIA CENTAUR XP DIGITOXIN ASSAY N/A 08861968 manufactured by Siemens Healthcare Diagnostics, Inc..
[3730436]
Falsely elevated advia centaur xp digitoxin results were obtained by the customer on two dialysis patient samples and questioned by the physician. One of the patient samples was sent to an alternate laboratory, tested on an alternate digitoxin test method and the result was lower. The lower result was within the therapeutic range and was what the physician expected. The customer sent both patient samples to an alternate laboratory for verification testing on another advia centaur system and the results were elevated. There was no known report of adverse health consequences due to the elevated advia centaur xp digitoxin results.
Patient Sequence No: 1, Text Type: D, B5
[11089999]
The cause for the falsely elevated advia centaur xp digitoxin result when compared to a lower repeat test result from an alternate test method for patient ((b)(6)) is unknown. This patient sample was tested in-house on an advia centaur system and the result was elevated. The sample was also treated with a heterophile blocking tube (hbt) for an unknown antibody interference and the result was elevated. The sample was serially diluted for possible interfering substances and the observed results were linear. The cause for the falsely elevated advia centaur xp digitoxin result for patient ((b)(6)) is unknown. The sample was tested on another advia centaur system at another laboratory and the result was elevated. It is unknown if this sample was tested on another digitoxin test method. There we no sample available for further investigation. It was noted that the customer performed an advia centaur digitoxin assay calibration using expired calibration material and their low quality control result was out of range limits at the time of the incident. The sample was sent to another laboratory for verification testing on another advia centaur system where their assay calibration had not expired and their quality control results were within range limits. The results for both patient samples were elevated. In summary, no conclusion can be drawn. Siemens in-house test results: sid advia centaur system digitoxin results alternate laboratory #1 - alternate test method result 42070863 54 ng/ml 16 ng/ml 53 ng/ml (sample treated with hbt) n/a note: linear results were observed with sample serial dilutions. Sid (b)(6): no sample provided for in-house testing. The instruction for use (ifu) states the following in the quality control section: "if the quality control results do not fall within the expected values or within the laboratory's established values, do not report results. Take the following actions: verify that the materials are not expired. Verify that required maintenance was performed. Verify that the assay was performed according to the instructions for use. Rerun the assay with fresh quality control samples. If necessary, contact your local technical support provider or distributor for assistance. " the instruction for use (ifu) states the following in the expected results section: "a therapeutic range of 10 to 30 ng/ml (13. 1 to 39. 2 nmol/l) has been previously reported for digitoxin. Digitoxin levels must be evaluated in conjunction with the complete clinical profile to provide effective therapy. The advia centaur dgtn assay utilizes a monoclonal antibody that demonstrates a high specificity to digitoxin. This may result in differences in reported results when compared to other tests due to cross reactivity differences with certain metabolites. Each laboratory should determine the appropriateness of this range for the diagnostic evaluation of patient results. "
Patient Sequence No: 1, Text Type: N, H10
[34643012]
Siemens filed the initial mdr 1219913-2013-00201 0n 09/06/2013 for falsely elevated digitoxin patient results. 09/16/2013 - additional information: it was unknown initially which patient the medications was prescribed for, however additional information has been provided and the prescribe medications was for patient (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2013-00201 |
| MDR Report Key | 3331171 |
| Report Source | 05,06 |
| Date Received | 2013-09-06 |
| Date of Report | 2013-08-14 |
| Date of Event | 2013-07-23 |
| Date Mfgr Received | 2013-09-09 |
| Date Added to Maude | 2013-12-05 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| 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 XP DIGITOXIN ASSAY |
| Generic Name | DIGITOXIN IMMUNOASSAY |
| Product Code | LFM |
| Date Received | 2013-09-06 |
| Model Number | N/A |
| Catalog Number | 08861968 |
| Lot Number | 194 |
| ID Number | N/A |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2013-09-06 |