MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,07 report with the FDA on 2008-10-10 for ADIVA CHEMISTRY TOTAL PROTEIN REAGENT KIT 01803350 manufactured by Siemens Healthcare Diagnostics Inc..
[946271]
During studies, it was observed that the advia chemistry total protein method did not meet claims of no significant interference at 1500 mg/dl dextran. There have been no reports of adverse health consequences due to positive discordant results.
Patient Sequence No: 1, Text Type: D, B5
[8195162]
Remedial action: the dextran interference section in the ifu will be revised to reflect current data.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2008-00118 |
| MDR Report Key | 1196535 |
| Report Source | 02,07 |
| Date Received | 2008-10-10 |
| Date of Report | 2008-09-12 |
| Date of Event | 2008-09-12 |
| Date Mfgr Received | 2008-09-12 |
| Date Added to Maude | 2009-06-24 |
| 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 | LINDAS BARLETTA |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | RANDOX LABORATORIES LTD |
| Manufacturer Street | COUNTY ANTRIM |
| Manufacturer City | CRUMLIN BT294QY |
| Manufacturer Country | EI |
| Manufacturer Postal Code | BT294QY |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADIVA CHEMISTRY TOTAL PROTEIN REAGENT KIT |
| Generic Name | TOTAL PROTEIN CHEMISTRY METHOD |
| Product Code | CEK |
| Date Received | 2008-10-10 |
| Model Number | NA |
| Catalog Number | 01803350 |
| Lot Number | 100789 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2008-10-10 |