MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-01-13 for IMMULITE 2000 0300002 manufactured by Siemens Healthcare Diagnostics Inc..
[18079448]
Analysis of the system data by a siemens technical service engineer (tse) indicated that there were no known causes which may have contributed to the discordant low immulite 2000 calcitonin results. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[18182888]
Discordant low calcitonin (cal) results were obtained on immulite 2000 for two (2) patient samples, drawn from the same patient on different dates. An initial low result was obtained for a sample drawn on (b)(6) 2010. A high result was obtained for a second sample drawn on (b)(6) 2010 (x100 dilution). The laboratory subsequently re-tested the initial sample, which had been stored frozen, and obtained a high result. (x100 dilution). All results were reported to the physician. Patient treatment was not altered or prescribed there was no report of adverse health consequences due to the discordant calcitonin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2011-00003 |
| MDR Report Key | 1960503 |
| Report Source | 05,06 |
| Date Received | 2011-01-13 |
| Date of Report | 2010-12-28 |
| Date of Event | 2010-10-21 |
| Date Mfgr Received | 2010-12-28 |
| Date Added to Maude | 2012-04-27 |
| 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 | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY ROAD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMUNO-ASSAY |
| Product Code | DGC |
| Date Received | 2011-01-13 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 0300002 |
| 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 INC. |
| Manufacturer Address | FLANDERS NJ 07835 US 07835 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-13 |