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

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.

• 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 Key: 17638888
• MDR Text Key: 322134983
• Report Number: 3006984151-2023-00003
• Device Sequence Number: 1
• Product Code: JJY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 88773
• Device Catalogue Number: 88773
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2023
• Distributor Facility Aware Date: 08/03/2023
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other