MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-02-09 for IMMULITE 2500 CALCITONIN L5KCL manufactured by Siemens Healthcare Diagnostics Inc.
[17392874]
A discordant low immulite calcitonin result was obtained on a previous frozen pt sample. The initial result did not correlate with the pt's clinical picture and was questioned by the physician. The sample was sent out to another laboratory per the customer's laboratory standard operating procedure and the calcitonin result was higher and correlated with the clinical picture. The sample was returned on the immulite 2500 and the repeat result correlated with the clinical picture. There was no report of pt treatment being altered or adverse health consequences due to the discordant low calcitonin assay result.
Patient Sequence No: 1, Text Type: D, B5
[17600585]
A siemens field service engineer (fse) was sent to the customer site and performed a functional sys eval. The fse was not able to determine the cause for the discordant low calcitonin result. The instrument is performing within specs. No further eval of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017183-2010-00005 |
| MDR Report Key | 1613115 |
| Report Source | 05,06 |
| Date Received | 2010-02-09 |
| Date of Report | 2010-01-11 |
| Date of Event | 2009-12-24 |
| Date Mfgr Received | 2010-01-11 |
| Date Added to Maude | 2011-04-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN ANDBERG |
| Manufacturer Street | 5210 PACIFIC CONCOURSE |
| Manufacturer City | LOS ANGELES CA 900455597 |
| Manufacturer Country | US |
| Manufacturer Postal | 900455597 |
| Manufacturer Phone | 5086608540 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 5700 WEST 96TH ST. |
| Manufacturer City | LOS ANGELES CA 90045559 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90045 5597 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2500 CALCITONIN |
| Generic Name | CALCITONIN IMMUNOASSAY |
| Product Code | JKR |
| Date Received | 2010-02-09 |
| Model Number | NA |
| Catalog Number | L5KCL |
| Lot Number | 123 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | LOS ANGELES CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-09 |