MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. LIPASE REAGENTS (4 X 160 TESTS); ADVIA 1800 CHEMISTRY - LIPASE (LIP)

Model Number ADVIA 1800 CHEMISTRY - LIPASE (LIP)

Device Problem Imprecision (1307)

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

Event Date 01/06/2020

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 observed multiple calibration failures and quality control (qc) imprecision while using lipase (lip) lot #485700 with advia 1800 chemistry.The customer did not indicate that patient results were affected by the calibration and qc issue and did not provide any patient results.There are no known reports of patient intervention or adverse health consequences due to the issue with lip reagent.

• Brand Name: LIPASE REAGENTS (4 X 160 TESTS)
• Type of Device: ADVIA 1800 CHEMISTRY - LIPASE (LIP)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; 55 diamond road; registration # 8020890; crumlin, BT29 4QY; UK BT29 4QY
• Manufacturer Contact: mardochee timolien ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242503
• MDR Report Key: 9613241
• MDR Text Key: 195110551
• Report Number: 2432235-2020-00116
• Device Sequence Number: 1
• Product Code: CHI
• UDI-Device Identifier: 00630414482446
• UDI-Public: 00630414482446
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/21/2020

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: 04/28/2020
• Device Model Number: ADVIA 1800 CHEMISTRY - LIPASE (LIP)
• Device Catalogue Number: 10311896
• Device Lot Number: 485700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2432235-01/02/2020-001-R
• Patient Sequence Number: 1