MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LIPC LIPASE COLORIMETRIC; LIPASE TEST SYSTEM

Catalog Number 07041918190

Device Problem High Test Results (2457)

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

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

A clinician stated that they received high test results using the lipc lipase colorimetric assay on the cobas 8000 c (701) module (c701) for patients who are taking the drug azathioprine.No patient information or test results were provided.The clinician stated that the test results did not match the clinical pictures of the patients.No further information was provided.There was no allegation of an adverse event.The c701 serial number is (b)(4).Investigation activities are ongoing.

Manufacturer Narrative

A specific root cause for this event could not be identified.Additional information was requested for investigation but was not provided.Azathioprin is not listed in the common panel of drugs which are tested prior to the introduction of a new assay; therefore, the drug is not listed in the product labeling as a limitation.The investigation identified information indicating pancreatitis is an adverse reaction of taking azathioprin; however, this was not accepted by the clinician.

• Brand Name: LIPC LIPASE COLORIMETRIC
• Type of Device: LIPASE TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6497590
• MDR Text Key: 73125007
• Report Number: 1823260-2017-00795
• Device Sequence Number: 1
• Product Code: CHI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2017

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 Catalogue Number: 07041918190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2017
• Initial Date FDA Received: 04/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1