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 2016-12-13 for IMMULITE 2000 CALCITONIN manufactured by Siemens Healthcare Diagnostics Products, Limited.
[62377122]
A siemens technical application specialist (tas) was dispatched to the customer site. The tas ran the patient sample in question using a heterophilic blocking tube and the result was acceptable. As per immulite 2000 calcitonin instructions for use, "heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays. Samples from patients routinely exposed to animals or animal serum products can demonstrate this type of interference potentially causing an anomalous result. These reagents have been formulated to minimize the risk of interference; however, potential interactions between rare sera and test components can occur. For diagnostic purposes, the results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other findings. " a siemens headquarters support center specialist reviewed the data provided by the customer and indicated that immulite 2000 calcitonin assay is performing as intended. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[62377123]
Discordant, falsely elevated calcitonin results were obtained on one patient sample on an immulite 2000 instrument upon initial and repeat testing, while using kit lot 259. The sample was repeated on an alternate immulite instrument, also resulting elevated. The sample was tested on an alternate platform and the result was lower. The discordant results were reported to the physician(s) and questioned. It is unknown if the corrected result obtained 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 discordant, falsely elevated calcitonin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00755 |
| MDR Report Key | 6169973 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-13 |
| Date of Report | 2016-12-13 |
| Date of Event | 2016-11-04 |
| Date Mfgr Received | 2016-11-18 |
| Date Added to Maude | 2016-12-13 |
| 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 PRODUCTS, LIMITED |
| Manufacturer Street | UK REGISTRATION #: 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, GWYNEDD 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 | IMMULITE 2000 CALCITONIN |
| Product Code | JKR |
| Date Received | 2016-12-13 |
| Model Number | IMMULITE 2000 CALCITONIN |
| Lot Number | 259 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 GWYNEDD, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-13 |