MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-04 for ADVIA CENTAUR XP DIGOXIN (DIG) ASSAY N/A 06794163 manufactured by Siemens Healthcare Diagnostics, Inc..
[39935300]
The cause for the false high advia centaur xp digoxin test results is unknown. The customer's quality control results were within acceptable ranges at the time of the event, and the customer has previously passed a cap survey for unknowns, and linearity testing. Siemens is investigating. The instrument is performing within specification.
Patient Sequence No: 1, Text Type: N, H10
[39935301]
A false high advia centaur xp digoxin (dig) result was obtained on a patient sample and considered discordant compared to a lower alternate test method result. Due to the initially high digoxin result, the patient was treated with digifab. The patient sample was tested at another laboratory (sister site) with an advia centaur xp system and the digoxin result was high. The patient sample was run on an alternate digoxin test method and the result was low. The alternate digoxin test method result was consistent with the patient's clinical history and a corrected report was issued. The emergency room (er) physician has questioned the validity of all the high advia centaur xp sample results. There was no report of adverse health consequences due to the discordant advia centaur xp result.
Patient Sequence No: 1, Text Type: D, B5
[45886041]
Siemens filed the initial mdr 1219913-2016-00046 on 03/04/2016 for a false high advia centaur xp digoxin (dig) result obtained on a patient sample. On 03/16/2016 additional information: the patient sample was returned and tested on the advia centaur xp digoxin assay. The sample was run neat, 1:2 dilution, heterophilic blocking tube (hbt), and 1:2 dilution with a hbt tube. All the results were >5. 0 ng/ml. The results indicate there is an interferent that is not attributed to non-specific binding, and inconclusive for the interference from heterophilic and/or non-specific binding antibodies, however another sample will be provided for further testing. Patient medications: acetaminophen, albuterol (proventil), alprazolam, aspirin, aspirin ec (halfprin), digoxin immune f (digifab), diltiazem (cardizem), famotidine (pepcid), fluticasone-salmeterol, furosemide (lasix), lisinopril (prinivil zestril), metoprolol succinate (toprol-xl), nitroglycerine, omeprazole (prilosec), pantoprazole (protonix), pneumococcal 13-valent conjugate vaccine, pravastatin, ranitidine (zantac), 0. 9% sodium chloride flush injection, tramadol (ultram), warfarin (coumadin).
Patient Sequence No: 1, Text Type: N, H10
[47808085]
Siemens filed the initial mdr 1219913-2016-00046 on 03/04/2016 for a falsely elevated advia centaur xp digoxin result , and mdr 2120016-2016-00046 supplemental report 1 for additional information. On 04/20/2016 additional information: the customer provided a second patient sample for further digoxin testing by siemens. The sample was tested on an advia centaur xp, and on three other alternate digoxin test methods. The advia centaur xp results were observed to be falsely elevated compared to the alternate digoxin test method results, and may be attributed to an unknown interfering substance. Siemens has requested additional patient information. Test results: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[58958366]
Siemens filed the initial mdr 1219913-2016-00046 on 03/04/2016 for a falsely elevated advia centaur xp digoxin result, mdr 2120016-2016-00046 supplemental report 1 filed on 04/06/2016, and mdr 2120016-2016-00046 supplemental report 2 filed on 05/12/2016 for additional information. On 06/01/2016 additional information: siemens is not able to obtain additional patient medical history or information for further investigation. Based on the digoxin test results from the returned sampled, and a review of the patient's medications, it has been determined that an interferent was the cause of the advia centaur xp elevated digoxin results, however not attributed to the common medications the patient was taking at the time of testing. The instrument is performing within specifications. No further investigation is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2016-00046 |
| MDR Report Key | 5480668 |
| Date Received | 2016-03-04 |
| Date of Report | 2016-10-26 |
| Date of Event | 2016-01-27 |
| Date Mfgr Received | 2016-06-01 |
| Device Manufacturer Date | 2015-05-22 |
| Date Added to Maude | 2016-03-04 |
| 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 | 3 |
| Event Location | 3 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP DIGOXIN (DIG) ASSAY |
| Generic Name | DIGOXIN IMMUNOASSAY |
| Product Code | KXT |
| Date Received | 2016-03-04 |
| Model Number | N/A |
| Catalog Number | 06794163 |
| Lot Number | 021216 |
| Device Expiration Date | 2016-05-22 |
| 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 | 2016-03-04 |