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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO DIAGNOSTICS, INC. TRUEBALANCE; BLOOD GLUCOSE SYSTEM
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NIPRO DIAGNOSTICS, INC. TRUEBALANCE; BLOOD GLUCOSE SYSTEM Back to Search Results
Model Number TRUEBALANCE
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/08/2015
Event Type  malfunction  
Event Description
Consumer complaint of about high blood results.Josh is calling on behalf of customer, (b)(6).Customer states that she feels well and requires no medical attention.Customer's expected blood results are 100-200mg/dl fasting.Verified the strips expire 05/31/2017.Customer confirms the strips are stored properly and were first opened (b)(6) 2015.Customer performed back to back blood test, 216mg/dl and 217mg/dl fasting.Reviewed meter memory: 321mg/dl, (b)(6) 2015, 01:08:00 pm, fasting:yes; 394mg/dl, (b)(6) 2015, 11:44:00 am, fasting:yes; 156mg/dl, (b)(6) 2015, 01:34:00 pm, fasting:yes; 260mg/dl, (b)(6) 2015, 10:05:00 am, fasting:yes; 40 mg/dl, (b)(6) 2015, 05:50:00 am, fasting:yes;.
 
Manufacturer Narrative
(b)(4).No product yet returned.
 
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Brand Name
TRUEBALANCE
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 Key4894469
MDR Text Key6069046
Report Number1052693-2015-01051
Device Sequence Number1
Product Code CGA
Combination Product (y/n)N
PMA/PMN Number
K090495
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Remedial Action Replace
Type of Report Initial
Report Date 06/30/2015
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 NumberTRUEBALANCE
Device Catalogue NumberH4H01-81
Device Lot NumberBR4569
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/08/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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