MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-02 for IMMULITE 2000 CALCITONIN L2KCL2 manufactured by Siemens Healthcare Diagnostics Inc..
[18415402]
A discordant calcitonin result was obtained on an immulite 2000 system for one (1) patient sample. The physician questioned the result and the sample was repeated in duplicate. The corrected report was given to the physician. There was no report of patient intervention or adverse health consequences due to the discordant calcitonin result.
Patient Sequence No: 1, Text Type: D, B5
[18698239]
A siemens field service engineer (fse) was sent to the customer site. Analysis of the immulite 2000 system indicates that there are no known system causes which may have contributed to the discordant calcitonin results. The system is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2010-00179 |
| MDR Report Key | 1918300 |
| Report Source | 05 |
| Date Received | 2010-12-02 |
| Date of Report | 2010-11-12 |
| Date of Event | 2010-11-08 |
| Date Mfgr Received | 2010-11-12 |
| Date Added to Maude | 2011-01-24 |
| 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 | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | GLYN RHONWY, LLANBERIS CAERMARFON |
| Manufacturer City | GWYNEDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 CALCITONIN |
| Generic Name | CALCITONIN |
| Product Code | JKR |
| Date Received | 2010-12-02 |
| Model Number | NA |
| Catalog Number | L2KCL2 |
| Lot Number | 217 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | LLANBERIS, GWYNEDD LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-02 |