• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY LIPASE REAGENT (LIP) Back to Search Results
Model Number ADVIA CHEMISTRY LIPASE (LIP)
Device Problem Imprecision (1307)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2019
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 they observed erratic qc and obtained discordant, falsely elevated lipase (lip) patient results using kit lot 485700 on an advia chemistry xpt instrument.The initial discordant, falsely elevated lip patient results were not reported to the physician(s).The same sample was repeated on the same advia chemistry xpt instrument, resulting lower and as expected.None of the results (initial or repeat) were reported since testing was part of a patient comparison study between two lots of lip.There are no known reports of patient intervention or adverse health consequences due to the discordant lip results.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
Manufacturer (Section G)
RANDOX LABORATORIES LTD.
55 diamond road
crumlin
registration # 8020890, BT29 4QY
UK   BT29 4QY
Manufacturer Contact
mir khan
511 benedict avenue
tarrytown, NY 10951
9145243074
MDR Report Key9577772
MDR Text Key199999704
Report Number2432235-2020-00030
Device Sequence Number1
Product Code CHI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial
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 Date04/28/2020
Device Model NumberADVIA CHEMISTRY LIPASE (LIP)
Device Catalogue Number10311896
Device Lot Number485700
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/18/2019
Initial Date FDA Received01/10/2020
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 Number2432235-01/02/2020-001-R
Patient Sequence Number1
-
-