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 2015-10-05 for IMMULITE 2000 XPI 030001-3 manufactured by Siemens Healthcare Diagnostics Inc..
[27502093]
The cause of the falsely low calcitonin result on the immulite 2000 xpi instrument is unknown. Siemens healthcare is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[27502094]
The customer has obtained a falsely low result on patient sample for the calcitonin assay on an immulite 2000 xpi. The same sample was run on an alternate platform and the result was higher. The initial result was reported and questioned by the physician (s) as it did not fit the clinical picture. The result on the alternate platform was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the falsely low result obtained on the immulite 2000 xpi.
Patient Sequence No: 1, Text Type: D, B5
[32492842]
Initial mdr 2247117-2015-00053 was filed on 10/52015. Additional information (10/13/2015): the customer contacted siemens customer care center (ccc). The customer indicated that based on interference testing for heterophilic antibodies the results have been discussed with the lab manager who has accepted the explanation for the discordant low calcitonin result. The customer has also indicated that the calcitonin assay is performing as per specifications and does not need any further assistance on this issue. The system is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2015-00053 |
| MDR Report Key | 5128401 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-10-05 |
| Date of Report | 2015-10-13 |
| Date of Event | 2015-06-15 |
| Date Mfgr Received | 2015-10-13 |
| Date Added to Maude | 2015-10-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS (REF#2517506) |
| Manufacturer Street | 500 GBC DRIVE P.O. BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 XPI |
| Generic Name | IMMULITE 2000 XPI |
| Product Code | JJQ |
| Date Received | 2015-10-05 |
| Model Number | IMMULITE 2000 XPI |
| Catalog Number | 030001-3 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY ROAD FLANDERS NY 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-05 |