MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105ELPKNA ELI LILY PINK; SYRINGE, PISTON

Model Number MMT-105ELPKNA

Device Problems Material Too Rigid or Stiff (1544); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Hyperglycemia (1905); Malaise (2359); Diabetic Ketoacidosis (2364); Polydipsia (2604)

Event Date 05/14/2023

Event Type  Injury  

Manufacturer Narrative

Per visual inspection: no physical damage to cartridge holder or inpen front and back shell was noted.Inpen did not pair with commercial mobile app.Received inpen 1/2 of travel.Performed encoder bond investigation and found that the encoder pattern wheel tabs rotating and traveling off the keyed slots of dose nut guides.Encoder pattern wheel should never rotate.This causes an unexpected travel of the encoder pattern wheel creating resistance to dial and dispensing.Plastic shavings contamination builds up found caused by encoder wheel tabs rubbing at the walls of the dose nut.Abrasions down the length of the dose nut.Unable to perform baseline/wireless functionality and displacement dose accuracy test.Performed battery investigation and battery measured 3.038v.No battery anomaly was noted.In conclusion: it was determined from destructive analysis that the difficult to dial/dose was caused by a pattern wheel misalignment due to an encoder base bond failure.This can affect insulin delivery.Encoder base bond failure can cause the encoder to not make electrical connections therefore, missing a count or if there is a short, you may have extra pulses which will cause inaccuracy or inpen not paring.Therefore, the customer concern of not able to dispensed insulin was confirmed.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.

Event Description

Information received by medtronic indicated that the customer experienced hyperglycemia and diabetic ketoacidosis with a blood glucose value of 277 mg/dl. troubleshooting was performed.  the customer was treated with the inpen and was hospitalized.The customer experienced symptoms such as feeling sick/unwell and increased thirst.The customer reported screw was not moving as intended. advised the customer to prime enough until the injection foot touches the plunger and insulin exits and the issue was not resolved.The screw does not move when the injection/dose button was pushed. no further patient complications were reported. the customer will discontinue the use of the device and the inpen was returned for analysis.

• Brand Name: INPEN MMT-105ELPKNA ELI LILY PINK
• 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: justin ellis ; 1223 world trade drive, 100; san diego, CA 92128 ; 7635265677
• MDR Report Key: 17077071
• MDR Text Key: 316663261
• Report Number: 3012822846-2023-01050
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 0000108620880003
• UDI-Public: (01)0000108620880003(17)230728(10)B0438
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2023
• Device Model Number: MMT-105ELPKNA
• Device Catalogue Number: MMT-105ELPKNA
• Device Lot Number: B0438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 91 KG