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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE CHOLESTECH LDX MULTIANLYTE CONTROLS; MULTI-ANALYTE CONTROLS
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ALERE SAN DIEGO, INC. ALERE CHOLESTECH LDX MULTIANLYTE CONTROLS; MULTI-ANALYTE CONTROLS Back to Search Results
Model Number 88773
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/18/2015
Event Type  malfunction  
Manufacturer Narrative
Control lot (c3091a) was associated with field action per capa-(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.No further investigation will be pursued under this case.
 
Event Description
Report received of controls outside of expected range high 1x for trg on l2.Trg=312 (range: 206-304).No comparative data submitted.No reported adverse patient sequela.No additional information provided.
 
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Brand Name
ALERE CHOLESTECH LDX MULTIANLYTE CONTROLS
Type of Device
MULTI-ANALYTE CONTROLS
Manufacturer (Section D)
ALERE SAN DIEGO, INC.
9975 summers ridge road
san diego CA 92121
Manufacturer Contact
ya-ling king
9975 summers ridge road
san diego, CA 92121
8588052084
MDR Report Key5274879
MDR Text Key32955240
Report Number2027969-2015-00990
Device Sequence Number1
Product Code JJY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Remedial Action Notification
Type of Report Initial
Report Date 09/18/2015
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
Device Operator Health Professional
Device Model Number88773
Device Lot NumberC3091A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/18/2015
Initial Date FDA Received12/08/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction Number2027969-08/25/15-001C
Patient Sequence Number1
Treatment
LDX2 ANALYZER NORTH AMERICAN VERSION
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