MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-03-20 for ADVIA CENTAUR XP 078-A011-03 manufactured by Siemens Healthcare Diagnostics Inc..
[5701197]
Discordant, false positive digoxin results were obtained on one patient sample on an advia centaur xp instrument. The discordant results were reported to the physician(s). The sample was repeated on an advia 1800 and a dimension instrument, resulting negative. A new draw was obtained from the patient and was tested on the same instrument and on both the alternate instruments, resulting positive on the same instrument while negative on the alternate instruments. A third draw was obtained from the patient, resulting in a similar pattern as that of second draw. It is unknown which corrected result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, false positive digoxin results.
Patient Sequence No: 1, Text Type: D, B5
[13083735]
The customer contacted a siemens customer care center (ccc) specialist and stated that they obtained false positive digoxin results. The customer stated that quality control (qc) for level 2 was out of range but was acceptable upon repeat testing. The customer also stated that the patient samples were run while qc was within range. The customer ran the patient samples using heterophilic blocking tubes (hbt) but the results remained unchanged. The customer also performed the manual dilutions of samples treated with heterophile blocking agents and a dilution of one not treated sample and the results increased with every dilution step. The customer suspects an interferant specific with the patient sample. The cause of discordant, false positive digoxin results on one patient sample is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00129 |
| MDR Report Key | 4619576 |
| Report Source | 01,05,06 |
| Date Received | 2015-03-20 |
| Date of Report | 2015-02-23 |
| Date of Event | 2015-02-13 |
| Date Mfgr Received | 2015-02-23 |
| Device Manufacturer Date | 2011-02-07 |
| Date Added to Maude | 2015-04-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED REGISTRATION NUMBER: 8020888 |
| Manufacturer City | CHAPEL LANE, SWORDS, CO., DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | KXT |
| Date Received | 2015-03-20 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A011-03 |
| 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 | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-20 |