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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO DAIGNOSTICS, INC. TRUETRACK; BLOOD GLUCOSE SYSTEM
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NIPRO DAIGNOSTICS, INC. TRUETRACK; BLOOD GLUCOSE SYSTEM Back to Search Results
Model Number TRUETRACK
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2015
Event Type  malfunction  
Event Description
Consumer complaint of defective meter lcd.Customer states the screen is no longer working.Therefore affecting her ability to determine her blood test result correctly.Broken lcd trace observed.Adverse event not reported.
 
Manufacturer Narrative
(b)(4).Device evaluated with defect found.Most likely underlying root cause of malfunction noted in the complaint: user mechanical stress.((b)(6) 2015).
 
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Brand Name
TRUETRACK
Type of Device
BLOOD GLUCOSE SYSTEM
Manufacturer (Section D)
NIPRO DAIGNOSTICS, 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 Key4894460
MDR Text Key6538379
Report Number1052693-2015-01042
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 06/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2015
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 NumberRR4518
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/05/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received06/05/2015
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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