MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CHOLESTECH LDX ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	14-874
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation still in progress.
Event or Problem Description
The customer reported experiencing a brief shock when using the cholestech ldx analyzer.The customer stated the shock occurred when they touched the run button to insert a cassette, and could not verify whether it was a static shock or an electrical shock.The reported shock did not lead to an injury or other adverse health outcome.
Event or Problem Description
The customer reported experiencing a brief shock when using the cholestech ldx analyzer.The customer stated the shock occurred when they touched the run button to insert a cassette, and could not verify whether it was a static shock or an electrical shock.The reported shock did not lead to an injury or other adverse health outcome.
Additional Manufacturer Narrative
D9, h3, h6, and investigation conclusion (below) updated to document return of the device and investigation outcome.Investigation conclusion: the case details were reviewed along with the complaint history for the reported electrical shock and abnormal noise issues and no indications of a systemic issue were identified.Review of the risk documents for this product found that the reported issues are within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information.The reported abnormal noise was observed and the source could not be identified.The customer had performed 1653 tests on the ldx analyzer, indicating the issue developed over time and due to wear and tear.The reported electrical shock was not observed.Complaints are tracked and trended on a monthly basis.

• Brand Name: CHOLESTECH LDX ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9942 mesa rim rd; san diego, CA 92121 ; 8588052506
• MDR Report Key: 24171433
• Report Number: 2027969-2026-00013
• Device Sequence Number: 9649950
• Product Code: JJE
• UDI-Device Identifier: 00810039380512
• UDI-Public: (01)00810039380512(10)442405(11)250205(240)14874MR
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120615
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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
• Operator of Device: Health Professional
• Device Model Number: 14-874
• Device Catalogue Number: 14-874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Male