MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY LIPASE REAGENT (LIP)

Model Number ADVIA CHEMISTRY LIPASE (LIP)

Device Problem Imprecision (1307)

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

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics, inc.Has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using advia chemistry lipase reagent lot 485700.Preliminary investigation has indicated that not all cartons within this reagent lot are impacted.An urgent medical device recall (umdr) chc 20-03.A.Us was sent to us customers and an urgent field safety notice (ufsn) chc 20-03.A.Ous was sent to ous customers in december 2019.The umdr and ufsn advise customers of the investigation with the advia chemistry lipase reagent lot 485700 and provide instructions to help determine if the lipase reagent cartons in their inventory are impacted.If the cartons in the customers inventory are not impacted, the customers are instructed to proceed to using the cartons according to the instructions for use.If the cartons in the customers inventory are impacted, the customers are instructed to discard the impacted cartons and can request replacement.The next reagent lot is expected to be available by february 2020.If replacement kits are not available, customers are instructed to test patient samples using an alternate methodology.

Event Description

The customer contacted siemens customer care center (ccc) to report that imprecision and calibration failures were observed for lipase (lip) while using kit lot 485700 on an advia 1800 instrument.Customer did not provide any patient results.There are no known reports of patient intervention or adverse health consequences due to imprecision and calibration failures for lip.

Manufacturer Narrative

Initial mdr 2432235-2020-00022 was filed on 10-jan-2020.Corrected information (14-jan-2020): corrected date of first event (09-december-2019).Section b3 was updated.

• Brand Name: ADVIA CHEMISTRY LIPASE REAGENT (LIP)
• Type of Device: ADVIA CHEMISTRY LIPASE REAGENT (LIP)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 9577742
• MDR Text Key: 203896284
• Report Number: 2432235-2020-00022
• Device Sequence Number: 1
• Product Code: CHI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: ADVIA CHEMISTRY LIPASE (LIP)
• Device Catalogue Number: 10311896
• Device Lot Number: 485700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Removal/Correction Number: 2432235-01/02/2020-001-R
• Patient Sequence Number: 1