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 2016-11-10 for IMMULITE 2000 CALCITONIN L2KCA2 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[59721136]
The customer contacted a siemens customer care center (ccc) specialist. The customer performed manual dilution for calcitonin. The customer did not add de-ionizer to the diluent prior to the dilution. The cause of the discordant calcitonin results on one patient sample is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[59721137]
Discordant calcitonin results were obtained on one patient sample when run neat vs. Diluted on an immulite 2000 xpi instrument, while using reagent lot 258. It is unknown which result was reported to the physician(s). There were no reports of patient intervention or adverse health consequences due to the discordant calcitonin result.
Patient Sequence No: 1, Text Type: D, B5
[63942517]
The initial mdr 2432235-2016-00686 was filed on november 10, 2016. Additional information (12/08/2016): a siemens headquarters support center specialist reviewed the data provided by the customer and stated that the customer saw higher recovery when manually diluting a sample. However, the customer did not add the required deionized (di) water to the diluent before performing the manual dilution. The customer has amended their standard operating procedure, so that if there is ever a need to perform a manual dilution in the future they will include di water at the correct ratio. Immulite 2000 calcitonin kit lot 258 is performing as intended. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00686 |
| MDR Report Key | 6092750 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-10 |
| Date of Report | 2016-12-27 |
| Date of Event | 2016-10-18 |
| Date Mfgr Received | 2016-12-08 |
| Date Added to Maude | 2016-11-10 |
| 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 | 2016-11-10 |
| Model Number | IMMULITE 2000 CALCITONIN |
| Catalog Number | L2KCA2 |
| Lot Number | 258 |
| 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 | REGISTRATION #: 3002806944 GLYN RHONWY LLANBERIS, GWYNEDD, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-10 |