ALERE CHOLESTECH LDX MULTIANLYTE CONTROLS 88773

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-11-20 for ALERE CHOLESTECH LDX MULTIANLYTE CONTROLS 88773 manufactured by Alere San Diego, Inc..

Event Text Entries

[31789570] Control lot (c3091a) was associated with field action per (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.
Patient Sequence No: 1, Text Type: N, H10


[31789571] Report received of unexpected high control values received outside of range for ldx multi-analyte controls (l1 & l2). Controls l1 high: tc=257 (133-187), hdl=67 (21-41), trg=212 (105-155), ldl=148 (96-142). No reported adverse patient sequela. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027969-2015-00948
MDR Report Key5241156
Report SourceHEALTH PROFESSIONAL
Date Received2015-11-20
Date of Report2015-09-18
Date of Event2015-09-18
Date Mfgr Received2015-09-18
Date Added to Maude2015-11-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactYA-LING KING
Manufacturer Street9975 SUMMERS RIDGE ROAD
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8588052084
Single Use3
Remedial ActionNO
Previous Use Code3
Removal Correction Number2027969-08/25/15-001C
Event Type3
Type of Report3

Device Details

Brand NameALERE CHOLESTECH LDX MULTIANLYTE CONTROLS
Generic NameMULTI-ANALYTE CONTROLS
Product CodeJJY
Date Received2015-11-20
Model Number88773
Lot NumberC3091A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALERE SAN DIEGO, INC.
Manufacturer Address9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2015-11-20

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