MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-05-14 for TRIGLYCERIDES_2 REAGENT, CONCENTRATED 10697575 manufactured by Siemens Healthcare Diagnostics Inc..
[5782231]
The customer carried out a correlation study using patient samples, between the triglycerides_2 concentrated (trig_c) assay and the triglycerides_2 assay on an advia chemistry 2400 instrument. The customer observed that the correlation between the two methods was not acceptable when using trig_c reagent lot 300275. It is unknown if any of the results obtained on the advia chemistry 2400 were reported to physician(s) there were no reports of adverse health consequences due to the results obtained for trig_c on the patient samples.
Patient Sequence No: 1, Text Type: D, B5
[13448433]
Siemens has confirmed a low bias at the higher end of the triglyceride assay range on patient, quality control (qc), and linearity samples of advia chemistry trig_c reagent lot 300275 compared to alternate in date lots of trig_c, trig and trig_2 reagents. During siemens investigation, the trig_c reagent lot 300275 displayed a low bias that exceeded 25% at levels greater than approximately 425mg/dl for patients and quality controls. A positive (high) bias of approximately +10% was observed in qc samples at values less than 100mg/dl. The low bias occurred just prior to expiration of the affected kit lot 300275. Siemens diagnostics is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00233 |
| MDR Report Key | 4770756 |
| Report Source | 01,05,06 |
| Date Received | 2015-05-14 |
| Date of Report | 2015-04-30 |
| Date of Event | 2014-12-09 |
| Date Mfgr Received | 2015-04-30 |
| Date Added to Maude | 2015-06-15 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | RANDOX LABORATORIES LTD |
| Manufacturer Street | 55 DIAMON 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 | 3 |
| Brand Name | TRIGLYCERIDES_2 REAGENT, CONCENTRATED |
| Generic Name | TRIGLYCERIDE_2 REAGENTS, CONCENTRATED |
| Product Code | CDT |
| Date Received | 2015-05-14 |
| Model Number | TRIGLYCERIDES_2 REAGENT, CONCENTRATED |
| Catalog Number | 10697575 |
| Lot Number | 300275 |
| 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 | 2015-05-14 |