MAUDE Adverse Event Report: UNOMEDICAL A/S ANIMAS INSET INFUSION SET

Model Number 100-181-00

Device Problem No Apparent Adverse Event (3189)

Patient Problems Diabetic Ketoacidosis (2364); Coma (2417)

Event Date 05/14/2016

Event Type  Injury  

Manufacturer Narrative

Unomedical clinical evaluation: the patient went into diabetic coma and was transported to hospital (the term diabetic coma referring to when physicians are confronted with unconscious patients about whom nothing is known except that patient have diabetes).Patient was treated with insulin injection and iv fluids.The patient reported not using infusion set and pump as per training and ifu and is therefore not in compliance with pump therapy for the treatment of diabetes.The patient did not report any health consequences due to this event.This case has been closed due to missing information.No relevant testing could be performed.Since the lot number is unknown, no batch record review or testing of retained samples could be performed.If the lot number or other new information becomes available, the case will be re-opened and appropriate actions will be taken.

Event Description

(b)(4).A (b)(6) female diabetic patient is receiving insulin treatment via an insulin pump and an animas inset infusion set.On (b)(6) 2016 (or (b)(6) 2016 ?) she is via 911 emergency protocol hospitalised in a comatose state presumably after a diabetic ketoacidosis.In hospital she is treated with insulin injections and i.V.Fluids.She comes out of coma on (b)(6) 2016.According to unomedical's source, animas, she discontinued pump therapy and remained hospitalised at time of contact to animas helpdesk.Patient informed animas helpdesk ((b)(6) 2016) that she only change infusion set every 5 or 6 days, only change insulin cartridge when it is empty, and that she does not adequately prime and does not fill the cannula (with insulin).She additionally states that her lack of 'carb counting' recently may be a contributing factor to her dka and hospitalization.We have no information on any presumed malfunction(s) of the infusion set involved.Nor do we know of the set lot number.

• Brand Name: ANIMAS INSET INFUSION SET
• Type of Device: INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, DK-43 20; DA DK-4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, DK-43 20; DA DK-4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, DK-43-20 ; 548167000
• MDR Report Key: 5696939
• MDR Text Key: 46484852
• Report Number: 3003442380-2016-00010
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 100-181-00
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 26 YR
• Patient Weight: 57