MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-05-14 for TRIGLYCERIDES_2 REAGENT, CONCENTRATED 10697575 manufactured by Siemens Healthcare Diagnostics Inc..
[5789982]
The customer carried out a correlation study using patient samples, between the triglycerides_2 concentrated (trig_c) assay and the triglycerides_2 assay on an advia chemistry 2400 instrument. The customer observed that the data obtained using the trig_c assay when using reagent lot 300275 was different that what was obtained using the trig_2 assay. It is unknown if any of the results obtained on the advia chemistry 2400 were reported to physician(s) there were no reports of adverse health consequences due to the results obtained for trig_c on the patient samples.
Patient Sequence No: 1, Text Type: D, B5
[13447625]
Siemens has confirmed a low bias at the higher end of the triglyceride assay range on patient, quality control (qc), and linearity samples of advia chemistry trig_c reagent lot 300275 compared to alternate in date lots of trig_c, trig and trig_2 reagents. During siemens investigation, the trig_c reagent lot 300275 displayed a low bias that exceeded 25% at levels greater than approximately 425mg/dl for patients and quality controls. A positive (high) bias of approximately +10% was observed in qc samples at values less than 100mg/dl. The low bias occurred just prior to expiration of the affected kit lot 300275. Siemens diagnostics is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[25381081]
The initial mdr 2432235-2015-00231 was filed on may 14, 2015. Supplemental mdr 2432235-2015-00231_s1 was filed on june 1, 2015. Additional information (07/13/15): the root cause of the low bias at the higher end of the triglyceride assay range on patient, quality control (qc), and linearity samples of advia chemistry trig_c reagent lot 300275 was determined to be a lower concentration of glycerokinase (gk) enzyme. The affected trig_c reagent lot 300275 expired on 12/31/2014. The customer has moved on to another lot that is unaffected.
Patient Sequence No: 1, Text Type: N, H10
[32590154]
The initial mdr 2432235-2015-00231 was filed on may 14, 2015. Additional information (05/06/15): an actual root cause has not been established as the affected lot has expired. The current lots are being monitored for linearity on a monthly basis until the end of shelf life.
Patient Sequence No: 1, Text Type: N, H10
[38903635]
The initial mdr 2432235-2015-00231 was filed on may 14, 2015. Supplemental mdr 2432235-2015-00231_s1 was filed on june 1, 2015. Supplemental mdr 2432235-2015-00231_s2 was filed on august 12, 2015. Additional information (1/20/2016): during the process of monitoring all current lots siemens technical operations has confirmed that the trig_c assay reagent lot 338040 which was being monitored through end of shelf life 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
[41735811]
The initial mdr 2432235-2015-00231 was filed on may 14, 2015. Supplemental mdr 2432235-2015-00231_s1 was filed on june 1, 2015. Supplemental mdr 2432235-2015-00231_s2 was filed on august 12, 2015. Supplemental mdr 2432235-2015-00231_s3 was filed on february 9, 2016. Correction: supplemental mdr #3 states, the date of awareness as 01/20/2016. The correct date is 01/13/2016. Additional information (2/29/2016): siemens could not conduct an investigation on trig_c reagent lot 300275 as it had expired. In date reagent lots 348297 and 359932 were monitored and based on internal studies siemens has confirmed that the two lots do not meet linearity claims as indicated in the instructions for use (ifu) of the assay. 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 to address reagent kit lots 348297 and 359932 only. Lot 300275 is expired and not part of this recall.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00231 |
| MDR Report Key | 4770750 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-05-14 |
| Date of Report | 2016-01-20 |
| Date of Event | 2014-12-16 |
| Date Mfgr Received | 2016-02-29 |
| Date Added to Maude | 2015-06-15 |
| 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 | TRIGLYCERIDE_2 REAGENTS, CONCENTRATED |
| Product Code | CDT |
| Date Received | 2015-05-14 |
| Model Number | TRIGLYCERIDES_2 REAGENT, CONCENTRATED |
| Catalog Number | 10697575 |
| Lot Number | 300275 |
| Device Availability | N |
| 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 | 2015-05-14 |