MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-02-26 for TRIGLYCERIDES_2 REAGENT, CONCENTRATED 10697575 manufactured by Siemens Healthcare Diagnostics, Inc..
[39088763]
Siemens technical operations has confirmed that the trig_c assay reagent lots 348297 and 359932 are not linear to the instructions for use (ifu) claim of 550 mg/dl (62. 15 mmol/l). Siemens diagnostics is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[39088764]
The customer has observed a drop in linearity for the triglycerides_2 concentrated assay when using reagent lot 348297 on the advia chemistry 2400 instrument. The linearity study was carried out on three different advia chemistry 2400 instruments. In addition a linearity study was also carried out on the new lot of triglyceride _2 reagent 359932. A comparison of data was provided between the two different reagent lots used for the linearity study. There were no reports of patient intervention or adverse health consequences due to the trig_c assay not meeting linearity claims.
Patient Sequence No: 1, Text Type: D, B5
[41946304]
The initial mdr 2432235-2016-00101 was filed on 2/26/2016. Additional information (2/29/2016): siemens healthcare diagnostics has confirmed the trig_c reagent kit lots 348297 and 359932( smn 10697575) used on the advia 1200, 1650, 1800, 2400, and xpt chemistry systems does not meet instructions for use (ifu) linearity claim at the upper limit of the assay range as it approaches end of shelf life. Internal testing demonstrated that a patient bias (-12% to -15%) may be seen at concentration levels between 450 to 550mg/dl. Linearity is reduced by approximately 31% at higher triglyceride concentrations up to 1200mg/dl (13. 56mmol/l). An urgent field safety notice (ufsn) chc16-03. A. Ous was sent to ous customers and a urgent medical device recall (umdr) chc16-03. A. Us was sent to us customers in march of 2016. The ufsn and umdr state that customers are to discontinue use and discard reagent kit lots 348297 and 359932.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00101 |
| MDR Report Key | 5462626 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-26 |
| Date of Report | 2016-02-08 |
| Date of Event | 2016-02-04 |
| Date Mfgr Received | 2016-02-29 |
| Date Added to Maude | 2016-02-26 |
| 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 | 3 |
| Event Location | 3 |
| 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. (REG# 8020890) |
| 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 |
| Removal Correction Number | 2432235-03/09/2016-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIGLYCERIDES_2 REAGENT, CONCENTRATED |
| Generic Name | TRIGLYCERIDES_2 REAGENT, CONCENTRATED |
| Product Code | CDT |
| Date Received | 2016-02-26 |
| Model Number | TRIGLYCERIDES_2 REAGENT, CONCENTRATED |
| Catalog Number | 10697575 |
| Lot Number | 348297, 359932 |
| Device Availability | * |
| Device Age | DA |
| 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 | 2016-02-26 |