MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-05-24 for ADVIA CHEMISTRY TRIGLYCERIDE METHOD B01-4133-01 manufactured by Siemens Healthcare Diagnostics, Inc..
[849347]
Customer reported a discordant triglyceride result when using reagent lot # 095939. The sample initially read 483 mg/dl and upon retest with a diluted sample, the corrected value was 2120 mg/dl. The customer became aware of this problem when she noticed that the reaction curve for the initial result was discrepant. There was no patient intervention as a result of this discordant triglyceride result.
Patient Sequence No: 1, Text Type: D, B5
[8079479]
Discussions with the oem reagent manufacturer indicates that the advia chemistry triglyceride method kit lot 095939 is exhibiting lower than expected linearity. The root cause. Investigation is under way by the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2008-00060 |
| MDR Report Key | 1051308 |
| Report Source | 05,06 |
| Date Received | 2008-05-24 |
| Date of Report | 2008-03-14 |
| Date of Event | 2008-02-25 |
| Date Mfgr Received | 2008-03-14 |
| Date Added to Maude | 2009-05-06 |
| 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 | 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 | 2008-05-24 |
| Model Number | NA |
| Catalog Number | B01-4133-01 |
| Lot Number | RGT. LOT # 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 | 2008-05-24 |