MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. LIPASE REAGENT

Model Number LIPASE REAGENT

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2015

Event Type  malfunction  

Event Description

The customer has obtained lower results on twenty samples for lipase.The sample values obtained on the first run were higher than when the samples were repeated on the same advia chemistry 2400 instrument.Eighteen of the twenty samples were rerun on an advia chemistry 1650 and the results were different.It is unknown if any of the results obtained on the advia chemistry 2400 or 1650 were reported to physician(s).There were no reports of adverse health consequences due to the results obtained for lipase on the patient samples.

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.The customer has received and implemented the protocol provided in the ufsn, and the issue has been resolved.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: LIPASE REAGENT
• Type of Device: LIPASE REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD; 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: 4712425
• MDR Text Key: 5662044
• Report Number: 2432235-2015-00193
• Device Sequence Number: 1
• Product Code: CHI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/26/2015

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: Other
• Device Model Number: LIPASE REAGENT
• Device Catalogue Number: B01-4840-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 04/21/2015
• 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: 2432235-03/24/2015-002-C
• Patient Sequence Number: 1