MAUDE Adverse Event Report: COMPANION MEDICAL INPEN

Model Number	INPEN
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: INPEN
• Manufacturer (Section D): COMPANION MEDICAL; 12230 world trade dr; suite 100; san diego, ca
• MDR Report Key: 10296191
• Report Number: 3012822846-2020-00004
• Device Sequence Number: 2496500
• Product Code: FMF
• UDI-Device Identifier: 10862088000313
• UDI-Public: 10862088000313
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR