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

Model Number TRUEBALANCE

Device Problem High Test Results (2457)

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

Event Date 05/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No product yet returned.

Event Description

Customer complaint of blood result reading of "hi." customer's wife states that her husband feels well and requires no medical attention.Customer's expected blood results are 200-300mg/dl fasting.Verified the strips expire 10/29/2017.Customer confirms the strips are stored properly but was unable to confirm when the test strips were first opened.Customer performed blood test, 589mg/dl fasting.Reviewed meter memory: hi mg/dl, (b)(6) 2015, 12:56:00 pm, fasting: yes; 237 mg/dl, (b)(6) 2015, 03:37:56 pm, fasting: yes; 81 mg/dl, (b)(6) 2015, 12:00:56 pm, fasting: yes; 37 mg/dl, (b)(6) 2015, 03:00:56 pm, fasting: yes; 288 mg/dl, (b)(6) 2015, 10:53:56 pm, fasting: yes.No adverse event reported.

Manufacturer Narrative

(b)(4).Product not returned for evaluation.Most likely underlying root cause is: strip issue.

• 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 Key: 4824597
• MDR Text Key: 22381486
• Report Number: 1052693-2015-00863
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/04/2015

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 Number: TRUEBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: PR2146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2015
• 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: Unknown
• Patient Sequence Number: 1