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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO DIAGNOSTICS, INC. TRUETRACK; BLOOD GLUCOSE SYSTEM
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NIPRO DIAGNOSTICS, INC. TRUETRACK; BLOOD GLUCOSE SYSTEM Back to Search Results
Model Number TRUETRACK
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2014
Event Type  malfunction  
Event Description
Consumer complaint test strips not working.Test strip lot mfr's expiration date is 05/31/2016 and open vial date is not verified.No adverse event reported.
 
Manufacturer Narrative
(b)(4).Returned test strips evaluated with defect found; showed indication of black chemistry.Most likely underlying root cause of malfunction noted in the complaint: improper storage of test strips in high humidity areas.Mfr acknowledges lateness of the report, per internal corrective action.This report should have been identified as reportable within 30 days of the identification ((b)(4) 2014).
 
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Brand Name
TRUETRACK
Type of Device
BLOOD GLUCOSE SYSTEM
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 Key4924423
MDR Text Key19007785
Report Number1052693-2015-01174
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 07/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2015
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 NumberRP4331
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/14/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received06/14/2014
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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