MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-02-05 for TRIGLYCERIDES_2 REAGENT, CONCENTRATED 10697575 manufactured by Siemens Healthcare Diagnostics, Inc..
[37576435]
Siemens technical operations has confirmed that the trig_c assay reagent lot 338040 is 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
[37576436]
The customer observed that linearity samples were not meeting specifications when using triglyceride_2 concentrated reagent lot 338040 on an advia 1800 chemistry system. The samples were run in triplicates and compared to the target value. Customer has observed that the assay is linear up to 450 mg/dl. The customer ran the linearity samples with another reagent lot for trig_c and the results were within specifications. None of the results from the linearity samples were released to the physician(s) there were no reports of patient intervention or adverse health consequences due to the linearity samples not meeting specifications.
Patient Sequence No: 1, Text Type: D, B5
[42038890]
The initial mdr 2432235-2016-00049 was filed on 2/5/2016. Correction: the initial mdr states the date of awareness as 01/20/2106. The correct date is 01/13/2016. 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 | 2432235-2016-00049 |
| MDR Report Key | 5412786 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-02-05 |
| Date of Report | 2016-01-20 |
| Date of Event | 2015-12-09 |
| Date Mfgr Received | 2016-02-29 |
| Date Added to Maude | 2016-02-05 |
| 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 | 2016-02-05 |
| Model Number | TRIGLYCERIDES_2 REAGENT, CONCENTRATED |
| Catalog Number | 10697575 |
| Lot Number | 338040 |
| 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 | 2016-02-05 |