MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CHEMISTRY LIPASE REAGENTS

Model Number ADVIA CHEMISTRY LIPASE REAGENTS

Device Problem Insufficient Information (3190)

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

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the high lipase result on the one patient sample is unknown.Siemens healthcare is investigating the issue.

Event Description

The customer has obtained high results on one patient sample for lipase assay on the advia chemistry 1800 instrument when using reagent lot 364967.The sample was run three times on the same instrument and the values were high.The sample was repeated on an alternate platform and the value was lower.The sample was re-run on another day on the same advia chemistry instrument and the values obtained were still high.The customer has indicated that the patient was hospitalized due to the high result.The initial results were reported to the physician(s).It is unknown if the results from the alternate platform were reported.There were no reports of patient intervention or adverse health consequences due to the high result for lipase.

Manufacturer Narrative

The initial mdr 2432235-2016-00285 was filed on 5/24/2016.Additional information (7/11/2016): the customer informed siemens healthcare that the contamination settings for the lipase assay was correct on the instrument.A siemens headquarters support specialist (hsc) reviewed the information provided by the customer.Based on the information provided the cause for the falsely high result could not be determined.Hsc provided troubleshooting steps to the customer to ensure that the system was performing per specifications.The customer has informed siemens that they are satisfied with the performance of the system.There have been no additional discordant patient results reported by the customer.The cause of the falsely high result for lipase is unknown.No further evaluation of the device is required.The system is performing according to specifications.

• Brand Name: ADVIA CHEMISTRY LIPASE REAGENTS
• Type of Device: ADVIA CHEMISTRY LIPASE REAGENTS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORES LTD. (REG# 8020890); 55 diamond road; crumlin; co. antrim, BT29 4QY; UK BT29 4QY
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 5675823
• MDR Text Key: 45780488
• Report Number: 2432235-2016-00285
• 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: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2016

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: No Information
• Device Model Number: ADVIA CHEMISTRY LIPASE REAGENTS
• Device Catalogue Number: 10311896
• Device Lot Number: 364967
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1