MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105NNBLNA NOVO NORDISK BLUE; SYRINGE, PISTON

Model Number MMT-105NNBLNA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Read Input Signal (1581); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown whether, or not the device may have caused, or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore, consider this report complete to the best of our knowledge.

Event Description

The customer¿s mother reported via phone call that the customer was hospitalized for high blood glucose and diabetic ketoacidosis.The customer¿s mother reported that the inpen dose calculator was not recommending the correct dose.She stated that the blood glucose values that were entered would disappear when she entered the carbs.This contributed to the customer having high blood glucose and being hospitalized.The customer was hospitalized on (b)(6) 2020, and stayed in the hospital for three days.Blood glucose reading at time of admission was 425 mg/dl.The customer was treated with iv insulin drip.It was also reported that the hyperglycemia was also contributed by the customer eating at night without delivering insulin.The customer¿s blood glucose at the time of the call was unknown.The insulin pen will not be returned for analysis.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.The follow up supplemental report was submitted with blank in the g4 section.The correct date is april 22, 2022.

Manufacturer Narrative

Update: section b5 customer snacks at night without taking insulin.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Update: customer snacks at night without taking insulin.

• Brand Name: INPEN MMT-105NNBLNA NOVO NORDISK BLUE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COMPANION MEDICAL INC; 1223 world trade drive, 100; san diego CA 92128
• Manufacturer (Section G): COMPANION MEDICAL INC; 1223 world trade drive, 100; san diego CA 92128
• Manufacturer Contact: neal grant ; 1223 world trade drive, 100; san diego, CA 92128
• MDR Report Key: 11023882
• MDR Text Key: 222013452
• Report Number: 3012822846-2020-00129
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-105NNBLNA
• Device Catalogue Number: MMT-105NNBLNA
• Device Lot Number: B93BW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2022
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 10 YR