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U.S. Department of Health and Human Services

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

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UNOMEDICAL A/S ANIMAS INSET INFUSION SET Back to Search Results
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.
 
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Brand NameANIMAS INSET INFUSION SET
Type of DeviceINFUSION 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 Key5696939
MDR Text Key46484852
Report Number3003442380-2016-00010
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
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 Received06/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number100-181-00
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2016
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 Treatment Data
Date Received: 06/03/2016 Patient Sequence Number: 1
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