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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEMOCUE AB HEMOCUE GLUCOSE 201 MICROCUVETTES; GLUCOSE TEST SYSTEM
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HEMOCUE AB HEMOCUE GLUCOSE 201 MICROCUVETTES; GLUCOSE TEST SYSTEM Back to Search Results
Model Number 111716
Device Problems Incorrect Or Inadequate Test Results (2456); High Test Results (2457); Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/12/2014
Event Type  malfunction  
Event Description
Hemocue received a complaint on hemocue glucose 201 microcuvettes from a us customer.The microvuvettes were reported as being discolored.No pt impact was reported by the customer.
 
Manufacturer Narrative
The customer complained on discolored microcuvettes.There is no pt impact reported.The customer returned the complained products and they were investigated by hemocue.A test of the measuring function showed that the returned microcuvettes in some cases measure to high.The maximum measuring error determined in this test was 25mg/dl.A capa has been opened to address the problem.
 
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Brand Name
HEMOCUE GLUCOSE 201 MICROCUVETTES
Type of Device
GLUCOSE TEST SYSTEM
Manufacturer (Section D)
HEMOCUE AB
angelholm
SW 
Manufacturer Contact
charlotte bengtsson, vp
p.o. box 1204
angelholm SE-26-2 23
SW   SE-262 23
MDR Report Key3987570
MDR Text Key22142913
Report Number3003044483-2014-00003
Device Sequence Number1
Product Code LFR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020935
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Remedial Action Replace
Type of Report Initial
Report Date 06/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/18/2014
Device Model Number111716
Device Lot Number1310258
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/08/2014
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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