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

Model Number MMT-105ELBLNA

Device Problems Computer Software Problem (1112); No Apparent Adverse Event (3189)

Patient Problem Hyperglycemia (1905)

Event Date 03/01/2022

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer reported via phone call that they experienced high blood glucose.Customer¿s blood glucose reading at the time of the incident was 400 md/dl.Customer stated that logged dose was greater than one unit.Troubleshooting was not performed for high blood glucose event.Customer will return the device for the analysis.No further customer complications were reported.

• Brand Name: INPEN MMT-105ELBLNA ELI LILY 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: tricha miles ; 1223 world trade drive, 100; san diego, CA 92128 ; 7635140379
• MDR Report Key: 13692513
• MDR Text Key: 286747646
• Report Number: 3012822846-2022-00211
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000313
• UDI-Public: (01)000010862088000313(17)230217
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/17/2023
• Device Model Number: MMT-105ELBLNA
• Device Catalogue Number: MMT-105ELBLNA
• Device Lot Number: B94TK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2022
• 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): Other
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 88 KG