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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO DIAGNOSTICS, INC. TRUE TRACK; BLOOD GLUCOSE SYSTEM
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NIPRO DIAGNOSTICS, INC. TRUE TRACK; BLOOD GLUCOSE SYSTEM Back to Search Results
Model Number TRUE TRACK
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/30/2015
Event Type  malfunction  
Event Description
Consumer complaint of high blood results.Customer's husband states his wife feels well and requires no medical attention.Customer's expected blood results are 120-200mg/dl fasting.Verified the strips expire 10/14/2017.Customer confirms the strips are stored properly and were first opened (b)(6) 2015.Reviewed meter memory: 529mg/dl (b)(6) 2015 10:44:00 am fasting yes; 406mg/dl (b)(6) 2015 09:09:00 am fasting yes; 257mg/dl (b)(6) 2015 03:49:00 am fasting no; 203mg/dl (b)(6) 2015 02:20:00 am fasting no; 211mg/dl (b)(6) 2015 01:23:00 am fasting no.Customers concern: 529/ 406.No adverse event reported.
 
Manufacturer Narrative
(b)(4).Product not yet evaluated.
 
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Brand Name
TRUE TRACK
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 Key4942221
MDR Text Key19007792
Report Number1052693-2015-01258
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 07/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberTRUE TRACK
Device Catalogue NumberA4H01-81
Device Lot NumberRS4652
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/14/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/30/2015
Initial Date FDA Received07/23/2015
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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