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

Model Number N/A

Device Problems Imprecision (1307); Low Test Results (2458)

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

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center (ccc) to report that a discordant, falsely depressed lipase (lip) patient sample test result was obtained on an advia chemistry 2400 instrument.The cause of the discordant, falsely depressed lip result is unknown.Siemens is investigating the issue.

Event Description

A discordant falsely depressed lipase (lip) result was obtained on one patient sample on an advia chemistry 2400 instrument.The initial discordant result for the patient was not reported to the physician(s).The original sample was repeated on the same advia chemistry 2400 instrument, resulting higher.It is unknown which result the customer considered to be correct.The customer did not consider the repeat result and sent the sample to an outside laboratory for analyzing.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed lip result.

Manufacturer Narrative

Siemens filed the initial mdr (b)(4) on (b)(6)2019.Additional information (18-dec-2019): 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.Sections b5, b6, h6, h7, h9, and h10 were updated.

Event Description

The customer obtained imprecise lipase (lip) patient and quality control (qc) results while using kit lot 485700 on an advia chemistry 2400 instrument.The initial patient results were not reported to the physician(s).The samples were repeated using the same advia chemistry 2400 instrument, but the repeat results were not reported to the physician(s).The customer did not consider a correct result and sent to another laboratory for analyzing.There are no known reports of patient intervention or adverse health consequences due to the discordant lip results.

• 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: 9418326
• MDR Text Key: 208325074
• Report Number: 2432235-2019-00443
• 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: 01/10/2020

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: N/A
• Device Catalogue Number: 10311896
• Device Lot Number: 485700
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 01/10/2020
• Removal/Correction Number: 2432235-01/02/2020-001-R
• Patient Sequence Number: 1
• Patient Age: 80 YR