MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-27 for ADVIA CENTAUR XP INSULIN (IRI) ASSAY N/A 02230141 manufactured by Kyowa Medex Co., Ltd. (japan) For:.
[2558098]
A high bias in quality control (qc) values was observed for the advia centaur xp insulin (iri) assay when using lot #85. The qc issues were resolved at the customer site with new reagent lot # 86. The customer repeated previous patient samples and the repeats were outside of the limit of acceptability. No results were reported. It is unknown if patient treatment was prescribed or altered. There was no report of adverse health consequences due to the discordant results.
Patient Sequence No: 1, Text Type: D, B5
[9592935]
The cause for the high bias in quality control (qc) for the advia centaur xp insulin (iri) assay when using lot #85 is unknown. Both siemens healthcare diagnostics and kyowa investigated the issue. The in-house and commercial qc results were within (b)(4) and the (b)(4) patient results were within (b)(4) the data for the qc and patients is within specifications. The instrument is performing within specification. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2012-00032 |
| MDR Report Key | 2429984 |
| Report Source | 05,06 |
| Date Received | 2012-01-27 |
| Date of Report | 2011-12-28 |
| Date of Event | 2011-09-30 |
| Date Mfgr Received | 2011-12-28 |
| Date Added to Maude | 2012-08-09 |
| 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 | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP INSULIN (IRI) ASSAY |
| Generic Name | INSULIN IMMUNOASSAY |
| Product Code | CFP |
| Date Received | 2012-01-27 |
| Model Number | N/A |
| Catalog Number | 02230141 |
| Lot Number | 085 |
| ID Number | N/A |
| Device Expiration Date | 2012-04-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KYOWA MEDEX CO., LTD. (JAPAN) FOR: |
| Manufacturer Address | SIEMENS HEALTHCARE DIAGNOSTICS TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-27 |