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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. LDX MULTI-ANALYTE CONTROLS (L1 AND L2); CHOLESTECH LDX MULTIANALYTE CONTROLS

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ALERE SAN DIEGO, INC. LDX MULTI-ANALYTE CONTROLS (L1 AND L2); CHOLESTECH LDX MULTIANALYTE CONTROLS Back to Search Results
Model Number 88773
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2023
Event Type  Injury  
Event Description
The customer reported that an end user placed his mouth on a vial of ldx multianalyte control when attempting to test the controls.As indicated in the package insert, the controls contain human and animal source material, and should be treated as potentially infectious.The end user did not seek medical attention and is currently not displaying symptoms.No adverse outcomes were reported.
 
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Brand Name
LDX MULTI-ANALYTE CONTROLS (L1 AND L2)
Type of Device
CHOLESTECH LDX MULTIANALYTE CONTROLS
Manufacturer (Section D)
ALERE SAN DIEGO, INC.
9942 mesa rim rd
san diego 92121
MDR Report Key17638888
MDR Text Key322134983
Report Number3006984151-2023-00003
Device Sequence Number1
Product Code JJY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/24/2023,08/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number88773
Device Catalogue Number88773
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/24/2023
Distributor Facility Aware Date08/03/2023
Event Location Nursing Home
Date Report to Manufacturer08/03/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/28/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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