MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. TRIGLYCERIDES_2 REAGENT, CONCENTRATED; TRIGLYCERIDE_2 REAGENTS, CONCENTRATED

Model Number TRIGLYCERIDES_2 REAGENT, CONCENTRATED

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

Siemens technical assay specialist (tas) during troubleshooting at the customer site carried out a correlation using seven high patient samples, between the triglycerides_2 concentrated (trig_c) assay and the triglycerides_2 assay on an advia chemistry 1800 instrument.Based on the results obtained tas noticed that the high samples showed a low bias with the trig_c assay when using reagent lot 300275.It is unknown if any of the results obtained on the advia chemistry 1800 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.

Manufacturer Narrative

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.

Manufacturer Narrative

The initial mdr 2432235-2015-00230 was filed on may 15, 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.

Manufacturer Narrative

The initial mdr 2432235-2015-00230 was filed on may 15, 2015.Supplemental mdr 2432235-2015-00230_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.

Manufacturer Narrative

The initial mdr 2432235-2015-00230 was filed on may 15, 2015.Supplemental mdr 2432235-2015-00230_s1 was filed on june 1, 2015.Supplemental mdr 2432235-2015-00230_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.

Manufacturer Narrative

The initial mdr 2432235-2015-00230 was filed on may 14, 2015.Supplemental mdr 2432235-2015-00230_s1 was filed on june 1, 2015.Supplemental mdr 2432235-2015-00230_s2 was filed on august 12, 2015.Supplemental mdr 2432235-2015-00230_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.

• Brand Name: TRIGLYCERIDES_2 REAGENT, CONCENTRATED
• Type of Device: TRIGLYCERIDE_2 REAGENTS, CONCENTRATED
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD. (REG# 8020890); 55 diamon road; crumlin; co. antrim, BT29 4QY; UK BT29 4QY
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 4775495
• MDR Text Key: 5782467
• Report Number: 2432235-2015-00230
• Device Sequence Number: 1
• Product Code: CDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TRIGLYCERIDES_2 REAGENT, CONCENTRATED
• Device Catalogue Number: 10697575
• Device Lot Number: 300275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 05/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/01/2015; 02/09/2016; 03/09/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2432235-03/09/2016-001-R
• Patient Sequence Number: 1