MAUDE Adverse Event Report: COMPANION MEDICAL INPEN

Model Number INPEN

Device Problem Low Readings (2460)

Patient Problem Hypoglycemia (1912)

Event Date 06/19/2020

Event Type  Injury  

Event Description

It was reported that a discrepancy occurred between the selected dose amount and (b)(6) logbook amount.On (b)(6) 2020, the patient dosed 5.5 units of insulin, however the logbook displayed 1.0 unit.The patient dosed an additional 4.5 units of insulin to accommodate the discrepancy.Consequently, the patient's blood glucose levels dropped to 37 mg/dl.The patient drank juice and injected glucagon to raise her blood glucose levels.Professional medical attention was not requested by the patient.This inpen was not returned, so an investigation was not possible and a root cause could not be determined.Cloud data was reviewed and supported customer allegation, however a root cause could not be determined.No additional information is available.

Event Description

The returned device was paired successfully to a samsung s10.Test doses of 5.0u were attempted five times.All doses were recorded accurately in the logbook, however some bluetooth latency was observed.The last three test doses were not displayed until the final 5th dose was dispensed and logged.The test was performed a second time and all doses were logged accurately in the logbook and no latency was observed- the doses were logged immediately.The patient's manually entered glucose data is contrary to the complaint description; the blood glucose levels were above 250 mg/dl.For the week of (b)(6) 2020.The customer complaint of dose log inaccuracies could not be confirmed and a root cause could not be determined.

Manufacturer Narrative

B5: narrative- additional.H2: type of report: additional.H3: device evaluation- additional.H6:type of investigation, investigation finding, conclusion - additional.

• Brand Name: INPEN
• Type of Device: INPEN
• Manufacturer (Section D): COMPANION MEDICAL; 12230 world trade dr; suite 100; san diego, ca
• MDR Report Key: 10296191
• MDR Text Key: 199675451
• Report Number: 3012822846-2020-00004
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10862088000313
• UDI-Public: 10862088000313
• Combination Product (y/n): N
• PMA/PMN Number: K192841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: INPEN
• Device Catalogue Number: INPEN-100EL-BL
• Device Lot Number: B93AN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR