MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-04-09 for IMMULITE 2000 030002 manufactured by Siemens Healthcare Diagnostics Inc..
[9888540]
Siemens filed the initial mdr 2247117-2010-00015 on (b)(4) 2010. Updated (b)(4) 2012: siemens received additional information from the customer specifying that the troponin patient result reported to the physician was 21. 8 ng/ml. The sample result was obtained on (b)(4) 2010 at 15. 25. 00 h.
Patient Sequence No: 1, Text Type: N, H10
[14868882]
Discordant low troponin results were obtained on one (1) patient sample. The discordant results were reported to the physician. The physician questioned the results due to the patient's history, and the sample was repeated. Patient treatment was not altered or prescribed. There was not report of adverse health consequences due to the discordant troponin results.
Patient Sequence No: 1, Text Type: D, B5
[15525131]
A siemens healthcare field service engineer (fse) was sent to the customer site for instrument evaluation. Analysis of the instrument and the instrument data indicate that the cause for discordant troponin results cannot be determined. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2010-00015 |
| MDR Report Key | 1656797 |
| Report Source | 05,06 |
| Date Received | 2010-04-09 |
| Date of Report | 2010-03-15 |
| Date of Event | 2010-03-10 |
| Date Mfgr Received | 2010-04-12 |
| Date Added to Maude | 2012-02-28 |
| 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 | BARBARA KVASNOSKY |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243658 |
| 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 | 2010-04-09 |
| Model Number | NA |
| Catalog Number | 030002 |
| Lot Number | NA |
| 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 | FLANDERS NJ 07835 US 07835 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-09 |