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..
[40160342]
Siemens healthcare diagnostics has confirmed the trig_c reagent kit lots 348297 and 359932 (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) 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
[40160343]
The customer has observed that linearity claims are not being met for the triglycerides_2 concentrated assay when using reagent lot 348297 and 359932 on the advia chemistry 1800 instrument. Based on the data generated the customer has observed that the assay is not linear above 300 mg/dl. The customer performed tests comparing neat, diluted, and manually diluted results on patient samples. None of the results were reported to the physician(s). There were no reports of patient intervention or adverse health consequences due to the failed linearity claim for the trig_2 assay.
Patient Sequence No: 1, Text Type: D, B5
[40551006]
The initial mdr 2432235-2016-00123 was filed on 3/10/2016. Correction: 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.
Patient Sequence No: 1, Text Type: N, H10
[75643153]
The initial mdr 2432235-2016-00123 was filed on march 10, 2016. Follow up mdr 2432235-2017-00123_s1 was filed on march 17, 2017. Corrected information (5/5/2017): upon further review of the complaint it was noted that the date of this report and date received by manufacturer was listed incorrectly in the initial mdr as 2/29/2016. The correct date is 3/3/2016. In addition it was indicated in describe event or problem of the initial mdr that results were not reported to the physician(s). The initial results were not reported to the physician (s), but corrected results were reported to the physician(s).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00123 |
| MDR Report Key | 5492126 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-10 |
| Date of Report | 2017-05-09 |
| Date of Event | 2016-03-02 |
| Date Mfgr Received | 2017-05-05 |
| 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, 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 | 2016-03-10 |