MAUDE Adverse Event Report: NIPRO DIAGNOSTICS, INC TRUERESULT; BLOOD GLUCOSE SYSTEM

Model Number TRUETRACK

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Product not yet returned for eval.(b)(4).

Event Description

Consumer c complaint of low blood results.Expected fasting blood glucose test result range 80 to 120 mg/dl.Expected blood glucose test results after meals is 180 mg/dl.Customer feels well and observed no symptoms.Medical intervention is not required at this time.Back to back blood test performed non-fasting during call on (b)(6) 2015 produced results of 69 mg/dl and 74 mg/dl.Verified storage of test strips is within instructed spec.Test strip lot mfr's expiration date is 10/31/2015 adn open vial date is (b)(6) 2015.Recall test results performed non-fasting from meter memory: 1: 56mg/dl, (b)(6) 2015, 11:57am, fasting: no; 2: 60mg/dl, (b)(6) 2015, 11:41am, fasting: no; 3: 49mg/dl, (b)(6) 2015, 11:40am, fasting: no; 4: 148mg/dl, (b)(6) 2015, 02:15pm, fasting: no; 5: 83mg/dl, (b)(6) 2015, 12:09pm, fasting: no; adverse event not reported.

Manufacturer Narrative

Product not returned for evaluation.Most likely underlying root cause is: user had an inaccurate reference.

• Brand Name: TRUERESULT
• 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
• MDR Report Key: 4824671
• MDR Text Key: 22382770
• Report Number: 1052693-2015-00837
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup

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: Health Professional
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RP4172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 06/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/16/2015
• 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: Initial
• Patient Sequence Number: 1