MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-27 for IMMULITE 2000 CALCITONIN L2KCL2 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[2797898]
Discordant high result(s) for calcitonin after thyroidectomy were obtained on an immulite 2000 instrument. A woman had high results for calcitonin. She had an operation - thyroidectomy, and after the operation she again had extremely high calcitonin results. A sample was tested in a different laboratory on a different system and the result was low.
Patient Sequence No: 1, Text Type: D, B5
[10035250]
The cause of discordant calcitonin results is unknown. The customer did not provide more information, data files, or a sample to be retested by the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2012-00072 |
| MDR Report Key | 2714735 |
| Report Source | 05,06 |
| Date Received | 2012-08-27 |
| Date of Report | 2012-07-30 |
| Date of Event | 2012-07-30 |
| Date Mfgr Received | 2012-07-30 |
| Date Added to Maude | 2012-12-12 |
| 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 | MR. MICHAEL METZ |
| Manufacturer Street | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | GLYN RHONWY LLANBERIS, CAERNARFON |
| Manufacturer City | GWYNEDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 CALCITONIN |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JKR |
| Date Received | 2012-08-27 |
| Model Number | IMMULITE 2000 CALCITONIN |
| Catalog Number | L2KCL2 |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Address | GLYN RHONWY LLANBERIS, CAERNARFON GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-27 |