MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC LIPASE; ABBOTT CLINICAL CHEMISTRY LIPASE

Catalog Number 07D80

Device Problem High Test Results (2457)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Abbott has confirmed that the package insert for the lipase reagent lots 43827uq12, 43819uq03, 44449uq05, 44127uq06, 44334uq07, 43994uq07, 44596uq08, 44775uq09, and 44930uq11 have incorrect smartwash parameters for triglyceride.The lipase assay is used for the quantitation of lipase in human serum or plasma.Pancreatic lipase in serum and plasma is closely associated with pancreatic diseases.The activity of this enzyme has been measured as an important marker for diagnosing pancreatic diseases and the associated monitoring of therapeutic effects.The insert indicates that the triglyceride cuvette smartwash assay parameter is not required on architect system software version 7.00 or higher; however, the triglyceride smartwash is required for the lipase assay for all software versions.The insert was correct beginning with lot 45200uq12.Due to this issue, there is the potential for generating false elevated lipase results.A falsely elevated lipase result may lead the physician to believe a patient has an acute or chronic pancreatitis or pancreatic duct constriction.The result may be in conflict with clinical findings in the evaluation of a patient with abdominal pain.This may lead to additional testing and delay of diagnosis and treatment of diseases other than pancreatitis.(b)(4).

Manufacturer Narrative

(b)(4).A product deficiency was identified and exception report (er) 357103 was initiated to further investigate the issue.The following corrective actions will be conducted in order to resolve this issue: the package insert of lot 45200uq12 has been corrected.Issue a product correction letter to all worldwide lipase reagent customers who received shipments of lots 43827uq12, 43819uq03, 44449uq05, 44127uq06, 44334uq07, 43994uq07, 44596uq08, 44775uq09, and 44930uq11.Product expiration date: lot number, expiration date: 43819uq03, 28 mar 2015, 44449uq05, 08 may 2015, 44127uq06, 02 jun 2015, 44334uq07, 01 jul 2015, 43994uq07, 29 jul 2015, 44596uq08, 27 aug 2015, 44775uq09, 24 sep 2015, 44930uq11, 25 nov 2015.

• Brand Name: LIPASE
• Type of Device: ABBOTT CLINICAL CHEMISTRY LIPASE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 847937-512
• MDR Report Key: 3768385
• MDR Text Key: 4378605
• Report Number: 1628664-2014-00069
• Device Sequence Number: 1
• Product Code: CHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/04/2014

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 Expiration Date: 12/25/2014
• Device Catalogue Number: 07D80
• Device Lot Number: 43827UQ12
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1628664-04/9/14-001-C
• Patient Sequence Number: 1
• Treatment: ARCHITECT SYSTEM INSTRUMENTS