MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-11 for ADVIA CHEMISTRY TOTAL PROTEIN II 10311878 manufactured by Siemens Healthcare Diagnostics Inc..
[133549250]
A siemens customer care center (ccc) specialist stated that the customer was using expired calibrator materials for the advia chemistry total protein ii assay.
Patient Sequence No: 1, Text Type: N, H10
[133549251]
Low total protein results were obtained with the advia chemistry total protein ii reagent. The customer was using expired calibrator materials for testing. No data has been provided by the customer. The customer stated that no results were questioned. There are no known reports of any impact to patients due to this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2019-00034 |
| MDR Report Key | 8240498 |
| Date Received | 2019-01-11 |
| Date of Report | 2019-01-11 |
| Date of Event | 2018-11-26 |
| Date Mfgr Received | 2018-12-19 |
| Date Added to Maude | 2019-01-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DEVYANI CHAUDHURI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242637 |
| Manufacturer G1 | RANDOX LABORATORIES LTD. |
| Manufacturer Street | REGISTRATION # 8020890 55 DIAMOND ROAD, CRUMLIN |
| Manufacturer City | CO. ANTRIM, BT294QY |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BT29 4QY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVIA CHEMISTRY TOTAL PROTEIN II |
| Generic Name | ADVIA CHEMISTRY TOTAL PROTEIN II |
| Product Code | CEK |
| Date Received | 2019-01-11 |
| Model Number | ADVIA CHEMISTRY TOTAL PROTEIN II |
| Catalog Number | 10311878 |
| Lot Number | 432852 |
| Device Expiration Date | 2019-05-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-11 |