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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 High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2015
Event Type  malfunction  
Event Description
Consumer complaint of high blood results.Customer states that she feels well and requires no medical attention.Customer's expected blood results are 90-135mg/dl fasting.Verified the strips expire 10/14/2017.Customer confirms the strips are stored properly and were first opened (b)(6) 2015.Customer performed back to back blood test, 126mg/dl and 130mg/dl fasting.Reviewed meter memory: 141mg/dl, (b)(6) 2015, 09:48:00 am, fasting: no; 88mg/dl, (b)(6) 2015, 07:02:00 pm, fasting: no; 110mg/dl, (b)(6) 2015, 07:00:00 am, fasting: no; 131mg/dl, (b)(6) 2015, 07:00:00 am, fasting: no; 116mg/dl, (b)(6) 2015, 06:57:00 am, fasting: no.Adverse event not reported.
 
Manufacturer Narrative
(b)(4).Product under evaluation.
 
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Brand Name
TRUETRACK
Type of Device
BLOOD GLUCOSE SYSTEM
Manufacturer (Section D)
NIPRO DIAGNOSTICS, INC.
2400 nw 55th ct.
fort lauderdale FL 33309
Manufacturer Contact
karen devincent
2400 n.w. 55th ct.
fort lauderdale, FL 33309
9546779201
MDR Report Key4924479
MDR Text Key6055651
Report Number1052693-2015-01134
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 07/10/2015
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 NumberRS4652
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/26/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received06/17/2015
Was Device Evaluated by Manufacturer? No
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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