MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION NOVA MAX LINK BLOOD GLUCOSE MONITOR

Model Number	N/A
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	08/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was discovered during troubleshooting the time stored in the meter is incorrect.Meter displayed 5:14pm however, the actual time was 11:51am.Time was corrected while on the line.The complainant's husband was not able to provide any of the inaccurate reading results nor could he provide any further information regarding the reported event.The caller was not able to provide information regarding the test strip lot number involved in the reported event.According to the caller, he is unsure of exact details on the day in question.Consumer receives insulin from her pump based on each reading per doctors orders.Caller stated she took the bg test and received insulin then went shopping.She crashed her car into a sign post after getting lost around 5:45 pm on the day in question.Emt's arrived on the scene and she was checked with their unk bg meter and the result was 33.She was given a glucose shot and came around shortly thereafter.Consumer declined a trip to the hospital and was driven home by her husband in his car as hers was towed away.Ts in question have since been used up and discarded.Unclear if cs test was performed on ts in question (cs was expired).Nova max test strip insert- quality control checking the system control solution test: the nova max control solution is used as a quality control check to make sure that your blood glucose monitor and the nova max glucose test strips are working correctly.Do a control solution test: each time you open a new vial of test strips.Storage and handling: keep the nova max glucose test strips vial tightly closed when not in use.Test strips should be stored only in the original vial.Meter is expected to be returned for evaluation.
Event or Problem Description
According to the complainant's husband, the complainant 'crashed her car' on (b)(6) 2017 due to a ".Hypoglycemic event possibly stemming from insulin taken based on an inaccurate blood glucose reading from her nova max link meter on the day in question.".

• Brand Name: NOVA MAX LINK BLOOD GLUCOSE MONITOR
• Common Device Name: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prosopect street; waltham MA 02454
• MDR Report Key: 6913579
• Report Number: 3004193489-2017-00027
• Device Sequence Number: 13804936
• Product Code: NBW
• UDI-Device Identifier: 00385480445856
• UDI-Public: 00385480445856
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 44585
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1