MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE CHOLESTECH LDX MULTIANALYTE CONTROLS; MULTI-ANALYTE CONTROLS

Model Number 88773

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2015

Event Type  malfunction  

Manufacturer Narrative

Mdr is being filed due to field action: ref-2027969-08/25/15-001c.Investigation pending.

Event Description

Customer reported that controls were outside of the expected range - high.Results were as follows: tc high two times for l1.Tc=160, 157 (108-152); trg=132 (129-191).The results were within the corrected expected values.Technical service reviewed factors and informed customer of notification; provided corrected expected values ranges and emailed the notification to the customer.

Manufacturer Narrative

Control lot c3091a was associated with field action per internal (b)(4) for incorrect expected value card provided with this control lot with the incorrect concentration assignment ranges for the total cholesterol and triglycerides analytes.Investigation will be performed under internal (b)(4).

• Brand Name: ALERE CHOLESTECH LDX MULTIANALYTE CONTROLS
• Type of Device: MULTI-ANALYTE CONTROLS
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5125624
• MDR Text Key: 27650076
• Report Number: 2027969-2015-00825
• Device Sequence Number: 1
• Product Code: JJY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dietician
• Remedial Action: Notification
• Type of Report: Followup
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88773
• Device Lot Number: C3091A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2027969-08/25/15-001C
• Patient Sequence Number: 1