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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

Date in meter is correct, however the time was incorrect.According to the complainant, nothing was different the day in question, no recent changes to her health, diet, exercise or medication.The complainant reported ".That her pump automatically administers her insulin at a scheduled time: 1.60 units at 7:00 am, 1.40 units at 2:00 pm and.950 units at 9:30 pm." she also reported that ".This is on an everyday basis, she makes 'no changes' to her intake at all no matter what." the consumer stated she last ate at approx.7:00 pm the night before.It is her regular time to eat, her meal was something she regularly eats.The consumer ate approx.5 minutes after testing at 9:02 am on (b)(6).She had cereal with milk and raw honey and a banana."her readings all usually all over the place" when asked what's her average reading.At approximately 12:00 pm the complainant stated ".She 'blacked out' and was involved in a 3 car crash due to her blood sugar." however, the complainant did say ".That she was 'feeling fine'." when the consumer gained consciousness, she immediately called her husband and the emt's were already at the scene.The emt's asked the consumer to check her bg, the consumer checked her bg at 12:29 pm using only her nml meter, once the emt's saw her bg reading at 53 they told the consumer take 4 sugar tablets and checked her sugar using her nml meter against their unk meter at 12:48 pm then again at 12:56 pm.Nothing was given to consumer in between bg readings.The emt's then asked the consumer if she wanted to be transported to the hospital and the consumer said her husband will take her.On her way to the hospital the consumer ate a burger with fries.According to the consumer she "felt fine" after the incident.When the consumer arrived at the hospital at approx.2:50 pm she was seen by a doctor at 3:40 pm and he checked her bg using her nml meter against his unk meter.The doctor stated that her bg was "fine and it was better that she was high than low".She was prescribed medication related to the accident (muscle relaxer and ibuprofen).The consumer was discharged within 40 minutes after seeing the doctor since there was "no damage physically and she was doing fine".The consumer did not test with her nml meter or at all after the incident.During the call to customer support, it was revealed that the consumer did not perform a control solution test for integrity before use their initial test strips as instructed in our directions for use.Per label copy/ package insert: - high or low blood glucose results can indicate potentially serious medical conditions.In case of an unexpected result, you should repeat the test using a new test strip.If the result is still unexpected, or the reading is not consistent with how you feel, contact your hcp and treat as prescribed.Any change in the treatment of your diabetes should be discussed with your hcp.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.Complainant returned the meter and test strips in question.The alleged deficiency could not be confirmed.Although the reported results were found in the memory of the returned device, failure analysis of the returned product revealed that the novamax link glucose monitoring device performed within specification.Visual as well as chemical evaluation (by testing with control solution) was not able to replicate the alleged issue as the performance testing revealed the strips to perform within specification as well.The dhr was complete and contained all relevant data indicating the product put into finished goods met all specifications.Dhr or retain testing could not be performed as the consumer was unable to provide test strip information.

Event Description

Complainant called in concerned about her readings and reported that ".Because of her blood sugar, she was involved in a car accident.".

Manufacturer Narrative

The complainant returned blood glucose test strip from the lot in question.Visual as well as chemical evaluation (by testing with blood) was not able to replicate the alleged issue as the performance testing revealed the strip to perform within specification as well.Dhr and retain testing was performed.

• Brand Name: NOVA MAX LINK BLOOD GLUCOSE MONITOR
• Type of Device: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prosopect street; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 39 manning road; billerica MA 01821
• Manufacturer Contact: rebecca figueria ; 200 prospect street; waltham, MA 02451 ; 9784393638
• MDR Report Key: 7154953
• MDR Text Key: 96621701
• Report Number: 3004193489-2017-00037
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00385480445856
• UDI-Public: 00385480445856
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 44585
• Device Lot Number: 1020916267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other