MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-16 for IMMULITE 2000 CALCITONIN manufactured by Siemens Healthcare Diagnostics Products, Limited.
[50621688]
The cause of the discordant, falsely elevated calcitonin results on one patient sample is unknown. Siemens healthcare diagnostics is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[50621689]
Discordant falsely elevated calcitonin results were obtained on an immulite 2000 xpi instrument for one patient on different samples while using reagent lots 254 and 256. The discordant results were reported to the physician(s). The patient underwent a procedure of computerized axial tomography (tac) due to the discordant results, which showed no pulmonary cancer growth. A new sample was obtained from the patient on (b)(6) 2016 and was tested neat and with different dilution factors on the same instrument, also resulting falsely elevated. The discordant results were reported to the physician(s), who questioned them. The sample was repeated on an alternate platform, resulting lower and matching the clinical picture of the patient. The corrected result was reported to the physician(s). There are no known reports of adverse health consequences due to the discordant, falsely elevated calcitonin results.
Patient Sequence No: 1, Text Type: D, B5
[55238444]
The initial mdr 2432235-2016-00381 was filed on july 15, 2016. Additional information (08/12/2016): a siemens headquarters support center (hsc) specialist could not determine the cause of the discordant, falsely elevated calcitonin result as the sample was not available for in-house testing. The hsc specialist indicated that the issue appears to be consistent with an interference on the immulite assay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00381 |
| MDR Report Key | 5800073 |
| Date Received | 2016-07-16 |
| Date of Report | 2016-08-19 |
| Date of Event | 2016-03-11 |
| Date Mfgr Received | 2016-08-12 |
| Date Added to Maude | 2016-07-16 |
| 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 | 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 | 2016-07-16 |
| Model Number | IMMULITE 2000 CALCITONIN |
| Lot Number | 254/256 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-07-16 |