MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-01-21 for ADVIA 2400 073-A010 manufactured by Siemens Healthcare Diagnostics Inc.
[1279794]
Discordant immunoglobulin m_2 (igm_2), results were obtained on an advia 2400 for 1 patient. The results were reported to the physician. The physician questioned the results. Due to the patient's history, the physician expected a result of approximately 30 g/l. Subsequent electrophoresis on the sample yielded a confirmatory result of 29 g/l. There were no reports of adverse health consequences or known patient interventions due to the discordant igm_2 results.
Patient Sequence No: 1, Text Type: D, B5
[8493906]
A siemens healthcare diagnostics inc. Field service engineer was not dispatched to the customer site. This appears to be a case of possible sample interference. No further conclusion can be drawn at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2010-00007 |
| MDR Report Key | 1585963 |
| Report Source | 05,06 |
| Date Received | 2010-01-21 |
| Date of Report | 2009-11-30 |
| Date of Event | 2009-11-23 |
| Date Mfgr Received | 2009-11-30 |
| Date Added to Maude | 2010-10-12 |
| 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 | JEOL LTD |
| Manufacturer Street | 3-1-2 MUSASHINO |
| Manufacturer City | AKISHIMA, TOKYO 196-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-8558 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2400 |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | CFN |
| Date Received | 2010-01-21 |
| Model Number | ADVIA 2400 |
| Catalog Number | 073-A010 |
| 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 | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-21 |