MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. LIPASE REAGENTS; CLINICAL CHEMISTRY ANALYZER

Model Number LIPASE REAGENTS

Device Problems Nonstandard Device (1420); High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2012

Event Type  malfunction  

Event Description

The customer reported lipase carryover after pack rollovers of cholesterol_c and triglyceride reagents on the advia chemistry 1800 instrument.The customer obtained falsely elevated patient results which were not repeatable on rerun.The results were not reported to the physician(s).There were no known reports of patient intervention or adverse health consequences reported.

Manufacturer Narrative

Siemens healthcare diagnostics has identified the potential for high biased advia® chemistry systems lipase assay results due to carryover from one or more of the following tests: triglycerides, triglycerides _2, triglycerides concentrated, cholesterol concentrated, and direct ldl reagents.The root cause of this issue was determined to be inadequate contamination avoidance settings between lipase and lipid panel assays (triglycerides, chol_c and dldl).An urgent medical device correction (umdc) 11220133, rev.A was sent to us customers and an urgent field safety notice (ufsn) 11220075, rev.A was sent to ous customers in march of 2015.The umdc and ufsn state that customers are advised to continue using the advia chemistry lipase reagents and follow the rerun instructions in the customer letter if a high outlier is observed.

Manufacturer Narrative

The initial mdr 2432235-2015-00138 was filed on march 25, 2015.(b)(4).

• Brand Name: LIPASE REAGENTS
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD. (REGISTRATION # 8020890); 55 diamond road; crumlin; co. antrim, BT29 4QY; UK BT29 4QY
• Manufacturer Contact: mindy losapio ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242312
• MDR Report Key: 4633034
• MDR Text Key: 5573422
• Report Number: 2432235-2015-00138
• Device Sequence Number: 1
• Product Code: CHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2015

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: Health Professional
• Device Model Number: LIPASE REAGENTS
• Device Catalogue Number: B01-4840-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 03/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2432235-03/24/2015-002-C
• Patient Sequence Number: 1