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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO DIAGNOSTICS, INC. TRUETRACK; BLOOD GLUCOSE SYS
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NIPRO DIAGNOSTICS, INC. TRUETRACK; BLOOD GLUCOSE SYS Back to Search Results
Model Number TRUETRACK
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/20/2014
Event Type  malfunction  
Event Description
Consumer complaint of erratic blood results.Back to back blood tests performed were "hi" (>600 mg/dl) and 336 mg/dl.No adverse event reported.
 
Manufacturer Narrative
(b)(4).Product evaluation completed with no defect found.Most likely underlying root cause of malfunction: user's misunderstanding of erratic (what is an acceptable variation between results).Remaining test strips and retention strips within specification.
 
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Brand Name
TRUETRACK
Type of Device
BLOOD GLUCOSE SYS
Manufacturer (Section D)
NIPRO DIAGNOSTICS, INC.
2400 n.w. 55th ct.
fort lauderdale FL 33309
Manufacturer Contact
karen devincent
2400 n.w. 55th ct.
fort lauderdale, FL 33309
9546779201
MDR Report Key3979631
MDR Text Key4889425
Report Number1052693-2014-00212
Device Sequence Number1
Product Code CGA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date 07/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberTRUETRACK
Device Catalogue NumberA4H01-81
Device Lot NumberRP4255
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received06/20/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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