MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-05-22 for ADVIA CHEMISTRY TRIGLYCERIDE METHOD B01-4133-01 manufactured by Siemens Healthcare Diagnostics, Inc..
[855347]
Customer reported discordant triglyceride results for several patients when they switched from triglyceride reagent lot 095939 to lot 102610. Upon review of the samples run with lot 095939, the customer found that there were no elevated results reported with this reagent lot. A review of samples run with the different reagent lot (102610) the customer found several samples reading over their rerun point of 6. 22 mmol/l. It is unknown at this time if there was any patient intervention as a result of these discordant triglyceride results.
Patient Sequence No: 1, Text Type: D, B5
[8021792]
Discussions with the oem reagent manufacturer indicates that advia chemistry triglyceride lot 095939 is exhibiting lower than expected linearity and root cause investigation is under way by the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2008-00047 |
| MDR Report Key | 1051297 |
| Report Source | 05,06 |
| Date Received | 2008-05-22 |
| Date of Report | 2008-04-21 |
| Date of Event | 2008-04-18 |
| Date Mfgr Received | 2008-04-21 |
| Date Added to Maude | 2009-05-08 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PETRA KANDUS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243392 |
| Manufacturer G1 | RANDOX LABORATORIES LTD |
| Manufacturer City | CRUMLIN, COUNTY ANTRIM BT294QY |
| Manufacturer Country | EI |
| Manufacturer Postal Code | BT294QY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY TRIGLYCERIDE METHOD |
| Generic Name | TRIGLYCERIDE METHOD |
| Product Code | JGY |
| Date Received | 2008-05-22 |
| Model Number | NA |
| Catalog Number | B01-4133-01 |
| Lot Number | REAGENT 095939 |
| ID Number | NA |
| Device Expiration Date | 2009-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2008-05-22 |