MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-03 for IMMULITE 2000 CALCITONIN manufactured by Siemens Healthcare Diagnostics Products, Limited.
[2735628]
High calcitonin results were obtained on an immulite 2000 instrument. Other samples of the same patient were tested in a different laboratory and the results were below the detection limit. There are no known reports of patient interventions or adverse health consequences due to the high calcitonin results.
Patient Sequence No: 1, Text Type: D, B5
[10091669]
A siemens field service engineer (fse) was dispatched to the customer site. The fse analyzed the instrument and instrument data. The cause of discordant calcitonin results is unknown. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00237 |
| MDR Report Key | 2681547 |
| Report Source | 05,06 |
| Date Received | 2012-08-03 |
| Date of Report | 2012-07-05 |
| Date of Event | 2012-06-14 |
| Date Mfgr Received | 2012-07-05 |
| Date Added to Maude | 2012-11-26 |
| 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. JOHN NELSON |
| Manufacturer Street | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 CALCITONIN |
| Generic Name | IMMULITE 2000 CALCITONIN |
| Product Code | JKR |
| Date Received | 2012-08-03 |
| Model Number | IMMULITE 2000 |
| Lot Number | 228 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-08-03 |