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  

Manufacturer Narrative

B3 - date of event: the date documented is an estimated date of occurrence provided by the customer.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.Manufacturing record review could not be performed as a lot number could not be obtained.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.Complaint details indicate that the end user deliberately placed his mouth on a vial of ldx multianalyte control when attempting to test the controls.As indicated in the package insert, the controls should be treated as potentially infectious, and a pipette is required to transfer the control material.The root cause of the issue is unsafe laboratory practices.There is no indication of a labeling deficiency.The multianalyte control package insert contains the precaution "human and animal source material.Treat as potentially infectious.The human source material used to produce this product has been tested using fda-accepted methods and found nonreactive for hepatitis b surface antigen (hbsag), and for antibodies to hepatitis c (hcv) and human immunodeficiency viruses (hiv-1 and hiv-2).Because no test can offer complete assurance that infectious agents are not present, this product should be considered potentially infectious and handled with the same precautions used with patient specimens." h3 other text : the device was disposed of by the customer.

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.

Manufacturer Narrative

B3 - date of event: the date documented is an estimated date of occurrence provided by the customer.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.Manufacturing record review could not be performed as a lot number could not be obtained.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.Complaint details indicate that the end user deliberately placed his mouth on a vial of ldx multianalyte control when attempting to test the controls.As indicated in the package insert, the controls should be treated as potentially infectious, and a pipette is required to transfer the control material.The root cause of the issue is unsafe laboratory practices.There is no indication of a labeling deficiency.The multianalyte control package insert contains the precaution "human and animal source material.Treat as potentially infectious.The human source material used to produce this product has been tested using fda-accepted methods and found nonreactive for hepatitis b surface antigen (hbsag), and for antibodies to hepatitis c (hcv) and human immunodeficiency viruses (hiv-1 and hiv-2).Because no test can offer complete assurance that infectious agents are not present, this product should be considered potentially infectious and handled with the same precautions used with patient specimens."b2: outcomes attributed to ae corrected from n/a to other serious h3 other text : the device was disposed of by the customer.

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 CA 92121
• Manufacturer Contact: monika burrell ; 9942 mesa rim rd; san diego, CA 92121 ; 8588052506
• MDR Report Key: 17620146
• MDR Text Key: 321924267
• Report Number: 2027969-2023-00078
• Device Sequence Number: 1
• Product Code: JJY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• 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
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other