MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE PARADIGM; COMFORT

Model Number	MMT-381600
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hypoglycemia (1912); Coma (2417)
Date of Event	04/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sincerely apologize the delay reporting of this event.The mdr reportability was identified during a quality check on 29jan2019.
Event or Problem Description
Unomedical reference number:(b)(4).A male diabetic patient was hospitalized on saturday (b)(6) 2018 at 3:30 am due to hypoglycemia and diabetic coma.Low blood glucose level of 1.7 mmol/l at time of event.The patient reported that he was in the hospital for few hours and was discharged on the same day.It was stated that the patient did not have a sensor and he fell in to diabetic coma in the night and went to the hospital.The patient reported that before going to sleep he noticed a bump on his skin and he thought that the bump was due to insulin stacking.It was reported that the patient changed the infusion set and site of insertion and gave himself a correction.The patient reported that he went to sleep and checked his blood glucose just before going to bed.It was stated that his wife noticed that he was sweaty and gave him orange juice and sugar.It was reported that the ambulance was called out and he was given glucagon injections to bring his blood glucose back to normal.It was reported that the cause of hospitalization per health care professional was low blood glucose.It was reported that the patient was not wearing the insulin pump at the time of hospitalization and was off the insulin pump less than forty eight hours.No further information available.

• Brand Name: SILHOUETTE PARADIGM
• Common Device Name: COMFORT
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• MDR Report Key: 8288254
• Report Number: 8021545-2019-00001
• Device Sequence Number: 2141085
• Product Code: FPA
• UDI-Device Identifier: 05705244008564
• UDI-Public: 05705244008564
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/01/2020
• Device Model Number: MMT-381600
• Device Lot Number: 5214444
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 01/30/2019
• 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: Hospitalization; Life Threatening