MAUDE Adverse Event Report: UNOMEDICAL A/S AUTOSOFT 90; INSULIN INFUSION SET

Model Number 1000282

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Coma (2417)

Event Date 10/06/2023

Event Type  Injury  

Event Description

Unomedical ref.(b)(4).Diabetic patient has experienced on (b)(6) 2023, a high blood glucose of 1000 mg/dl.Patients' wife called 911 when patient lost consciousness and had injury in the lower back by falling.Unomedical a/s has requested hospitalization information regarding this incident, but the provided information did not define specifically how long the patient was in a coma or if it was a coma or just loss of consciousness.The patient suspect fall of infusion set tap to be a probable cause for high bg.Hcp stated that the patient has a congestive heart failure.No other consequences or permanent damage to patient body structure or function are reported.No more information available.

Manufacturer Narrative

As no used or unsed samples have been returned, and the lot number is unknown, unomedical cannot perform further investigation.

• Brand Name: AUTOSOFT 90
• Type of Device: INSULIN INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted, lejre 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICALA/S; aaholmvej1-3; osted, lejre 4320 ; DA 4320
• Manufacturer Contact: aaholvej1-3; osted, lejre 4320
• MDR Report Key: 18473983
• MDR Text Key: 332382504
• Report Number: 3003442380-2024-00001
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244014572
• UDI-Public: 05705244014572
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K032854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1000282
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization