MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. LDX V2 ANALYZER NORTH AMERICAN VERSION; CHOLESTECH LDX ANALYZER

Model Number	14-874
Medical Device Problem Codes	Material Frayed (1262); Sparking (2595); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results pending completion of the investigation.H3 other text : although requested, the customer indicated the power-supply was discarded.
Event or Problem Description
The customer reported observing sparks from their frayed cholestech ldx analyzer power-supply during the performance of a hard reboot.The analyzer had not recently been moved or dropped and the analyzer was set up on a dry, stable surface with no other instruments around.Technical services attempted to gather additional information on the location of the fray and spark on the power supply, however the customer could not provide additional details and indicated the power supply had been discarded.No injury or harm reported.No further information was provided.
Additional Manufacturer Narrative
Investigation conclusion: the case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Review of the risk documents for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information.Complaints are tracked and trended on a monthly basis.H6 - adverse event problem and h10 - additional mfg narrative were updated as the investigation was completed.H6 - adverse event problem: medical device problem code was previously submitted as "a0714 unintended electrical shock" and should have been submitted as "a0704 sparking" and "a040605 material deformation: material frayed".H3 other text : although requested, the customer indicated the power-supply was discarded.
Event or Problem Description
The customer reported observing sparks from their frayed cholestech ldx analyzer power-supply during the performance of a hard reboot.The analyzer had not recently been moved or dropped and the analyzer was set up on a dry, stable surface with no other instruments around.Technical services attempted to gather additional information on the location of the fray and spark on the power supply, however the customer could not provide additional details and indicated the power supply had been discarded.No injury or harm reported.No further information was provided.

• Brand Name: LDX V2 ANALYZER NORTH AMERICAN VERSION
• Common Device Name: CHOLESTECH LDX ANALYZER
• 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: 17821846
• Report Number: 2027969-2023-00088
• Device Sequence Number: 14983656
• Product Code: JJE
• UDI-Device Identifier: 00810039380307
• UDI-Public: (01)00810039380307
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/22/2024

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown