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 2016-03-10 for TRIGLYCERIDES_2 REAGENT, CONCENTRATED 10697575 manufactured by Siemens Healthcare Diagnostics, Inc..
[40134037]
Siemens healthcare diagnostics has confirmed the trig_c reagent kit lots 348297 and 359932( smn (b)(4)) 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) (b)(4)ous was sent to ous customers and a urgent medical device recall (umdr) chc16-03. A. Us was sent to us customers in (b)(6) 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
[40134038]
The customer has observed that the linearity claims for the triglycerides_2 concentrated assay are not being met when using reagent lot 348297 on the advia chemistry 2400 instrument. High patient samples when diluted report results higher than the result obtained on a sample when run neat. The high result obtained on the diluted patient sample matches with the expected result. It is unknown if the results were reported to the physician(s). 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
[40549214]
The initial mdr 2432235-2016-00124 was filed on 3/10/2016. Corrected information: in the initial mdr the date of event was indicated as (b)(6) 2016. The customer has informed siemens diagnostics on (b)(6) 2016, that the correct date of event is (b)(6) 2016. Additional information (3/16/2016): in the initial mdr it was unknown if the patient results were reported to the physician(s). The customer has informed siemens healthcare that results above 400 ng/dl were not reported to physicians(s). The customer confirms all samples >400 ng/d with dilutions.
Patient Sequence No: 1, Text Type: N, H10
[40549215]
Results above 400 ng/dl were not reported to physicians(s). The customer confirms all samples >400 ng/d with dilutions.
Patient Sequence No: 1, Text Type: D, B5
[41977882]
The initial mdr 2432235-2016-00124 was filed on 3/10/2016. The dates were incorrectly listed as (b)(6) 2016 and 03/02/2016 in the event date and report date fields respectively. The correct dates are 03/02/2016 for report date and 02/29/2016 for date received by mfr.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2432235-2016-00124 |
MDR Report Key | 5492114 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
Date Received | 2016-03-10 |
Date of Report | 2016-03-02 |
Date of Event | 2016-03-01 |
Date Mfgr Received | 2016-03-16 |
Date Added to Maude | 2016-03-10 |
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 |
Remedial Action | RC |
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 | 2016-03-10 |
Model Number | TRIGLYCERIDES_2 REAGENT, CONCENTRATED |
Catalog Number | 10697575 |
Lot Number | 348297 |
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 | 2016-03-10 |