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 2016-08-16 for TRIGLYCERIDES_2 REAGENT, CONCENTRATED 10697575 manufactured by Siemens Healthcare Diagnostics, Inc..
[52547505]
Siemens healthcare diagnostics has confirmed the advia chemistry triglyceride concentrated reagent (trig_c) does not meet instructions for use (ifu) linearity claim at the upper limit of the assay range as it approaches end of shelf life for kit lot 365096. Internal testing indicates that a patient bias (-7% to -12%) may be seen at concentration levels from 550 to 600 mg/dl (6. 22 to 6. 78 mmol/l). Linearity is reduced by approximately 50% at triglyceride concentrations approaching the upper end of the extended range of 1100 mg/dl (12. 43 mmol/l). Quality control (qc) material may not detect this issue depending on the triglyceride concentrations in the qc material. Siemens internal testing has confirmed all other in date lots are currently meeting linearity ifu claims. However, as a precaution, until root cause is determined, a short term mitigation of reducing the expiration date to 6 months for all lots of advia chemistry systems triglyceride concentrated has been implemented. An urgent field safety notice (ufsn) chc16-03a. A. Ous was sent to ous customers and a urgent medical device recall (umdr) chc16-03a. A. Us was sent to us customers in august of 2016. The ufsn and umdr state that customers are to discontinue use and discard reagent kit lot 365096.
Patient Sequence No: 1, Text Type: N, H10
[52547506]
Customer was running quality control and confirmed a linearity performance issue exhibiting reduced upper end recovery below 500mg/dl with advia chemistry triglycerides concentrated assay (trig_c) kit lot 365096. Customer moved to a new lot of trig_c (kit lot 379597) which performed with better recovery. System is fully functional. No further action required. There were no reports of patient intervention or adverse health consequences due to the reduced upper end recovery below 500mg/dl.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00476 |
| MDR Report Key | 5878237 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-08-16 |
| Date of Report | 2016-08-16 |
| Date of Event | 2016-08-10 |
| Date Mfgr Received | 2016-08-10 |
| Date Added to Maude | 2016-08-16 |
| 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 | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | RANDOX LABORATORIES LTD (REG # 8020890) |
| Manufacturer Street | 55 DIAMON ROAD |
| Manufacturer City | CRUMLIN, CO. ANTRIM BT29 4QY, |
| Manufacturer Country | UK |
| 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 | 2016-08-16 |
| Model Number | TRIGLYCERIDES_2 REAGENT, CONCENTRATED |
| Catalog Number | 10697575 |
| Lot Number | 365096 |
| Device Availability | * |
| 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 | 2016-08-16 |