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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S MIO - MMT-921 INFUSION SET

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UNOMEDICAL A/S MIO - MMT-921 INFUSION SET Back to Search Results
Model Number MMT-921
Device Problems Bent (1059); Kinked (1339); Failure to Infuse (2340)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Coma (2417)
Event Date 02/20/2015
Event Type  malfunction  
Manufacturer Narrative
Unomedical clinical evaluation: (b)(6) 2016: the patient reported medical intervention was required due to diabetic ketoacidosis. Patient was treated with iv insulin. Available information at this time states that patient was admitted to hospital for 1 day and had to prove to health care professional that patient was able to self-treat. Doctor wanted to be sure that patient could treat high blood glucose level before release. If patient is not patient is not to use pump therapy to treat diabetes. The patient reported this event was due to bent cannula. No used set is returned for testing. There is no information if patient tried to self-treat and if patient measured blood glucose level regularly as per ifu/training. Patient reported vomiting and at one time passing out. More information is necessary to evaluate if patient was acting per training/ifu as patient is trained to rescue themselves to avoid diabetic ketoacidosis. 26-jan-2016 no new information from follow-up questions available. Not enough information to perform a proper clinical evaluation. 01-feb-2016 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 becomes available, the case will be re-opened and appropriate actions will be taken. Unomedical comment on time of reporting: due to a human error in the complaint handling process this case is reported quite late.
 
Event Description
(b)(4). A (b)(6) female diabetic patient informs medtronic's helpdesk that she has recently been in a coma with blood glucose at around 1000 mg/dl. She vomited violently and passed out. She was hospitalized via the emergency room at the (b)(6) medical center in (b)(6), diagnosed with diabetic ketoacidosis. There she was stabilized with i. V. Insulin. After a day or two in hospital she was discharged with normal blood glucose values. She noted, that when removing the infusion set, the cannula was bent. She suspect this to be the cause of her elevated blood glucose and ketoacidosis. About a year earlier she had also noted a bent cannula at time of infusion set removal (no further info available).
 
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Brand NameMIO - MMT-921
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 Key5403575
MDR Text Key37271156
Report Number3003442380-2016-00001
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 02/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-921
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 Received03/09/2015
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: 02/02/2016 Patient Sequence Number: 1
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