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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S QUICK-SET PARADIGM INSULIN INFUSION SET

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UNOMEDICAL A/S QUICK-SET PARADIGM INSULIN INFUSION SET Back to Search Results
Model Number MMT-397
Device Problem Bent (1059)
Patient Problems Hyperglycemia (1905); Heart Failure (2206); Diabetic Ketoacidosis (2364); Coma (2417)
Event Date 03/10/2016
Event Type  Injury  
Manufacturer Narrative
On 11-nov-2016: this is an initial mdr report. We are actively seeking more information. Presently we cannot exclude that infusion set(s) may have been a confounding/contribution factor. New information >>may<< cause us to withdraw the mdr submission if it conclusively is demonstrated that only insulin pump failure(s) caused the coma, heart failure and hospitalisation.
 
Event Description
(b)(4). This case was at first assessed as a pump-related case with respect to coma and hospitalisation. Due to erring at the side of caution, we have re-assessed the case today as possibly also being infusion set related. Unomedical is actively seeking more information on this case. A male diabetic patient is receiving insulin via an insulin pump and an insulin infusion set. He reports a number of issues seemingly pump-related over recent time including elevated blood glucose (bg) levels of up to 500 mg/dl. He further reports a hospitalisation on (b)(6) 2016 due to diabetic ketoacidosis (dka), coma, heart failure and 'flat lining'. Patient is transferred from er at (b)(6) to (b)(6) and released (b)(6) 2016. Most of the available information points to pump issues/failure(s) being the root cause of his problems. However, the information also contain the text "significant events leading to the hospitalization: he has been running high bg and few bent cannulas and a no delivery alarm. " due to this, we cannot presently completely exclude that infusion set(s) may have been confounding/contributing factor(s) leading up to the coma and subsequent hospitalisation.
 
Manufacturer Narrative
On 11-nov-2016: this is an initial mdr report. We are actively seeking more information. Presently we cannot exclude that infusion set(s) may have been a confounding/contribution factor. New information >>may<< cause us to withdraw the mdr submission if it conclusively is demonstrated that only insulin pump failure(s) caused the coma, heart failure and hospitalisation. On 25-apr-2017: no further information can be obtained. Case is closed. If new relevant information become available, case will be re-opened and re-submitted.
 
Event Description
(b)(4). This case was at first assessed as a pump-related case with respect to coma and hospitalisation. Due to erring at the side of caution, we have re-assessed the case today as possibly also being infusion set related. Unomedical is actively seeking more information on this case. A male diabetic patient is receiving insulin via an insulin pump and an insulin infusion set. He reports a number of issues seemingly pump-related over recent time including elevated blood glucose (bg) levels of up to 500 mg/dl. He further reports a hospitalisation on (b)(6) 2016 due to diabetic ketoacidosis (dka), coma, heart failure and 'flat lining'. Patient is transferred from er at (b)(6) medical center, (b)(6) to (b)(6) medical center, (b)(6) and released (b)(6) 2016. Most of the available information points to pump issues/failure(s) being the root cause of his problems. However, the information also contain the text "significant events leading to the hospitalization: he has been running high bg and few bent cannulas and a no delivery alarm". Due to this, we cannot presently completely exclude that infusion set(s) may have been confounding/contributing factor(s) leading up to the coma and subsequent hospitalisation. On 25-apr-2017: no further information can be obtained. Case is closed. If new relevant information become available, case will be re-opened and re-submitted.
 
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Brand NameQUICK-SET PARADIGM
Type of DeviceINSULIN 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 Key6095418
MDR Text Key59719150
Report Number3003442380-2016-00017
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011071
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2017
Device Model NumberMMT-397
Device Lot Number5056237
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2014
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: 11/11/2016 Patient Sequence Number: 1
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