• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

UNOMEDICAL A/S INSET INFUSION SET Back to Search Results
Model Number 100-183-00
Device Problem No Apparent Adverse Event (3189)
Patient Problems Death (1802); Hypoglycemia (1912); Coma (2417)
Event Date 04/30/2016
Event Type  Death  
Manufacturer Narrative
The lot reference samples were tested for visual to the adhesive tape, flow, leak, needle, click and serter tests. All tests were found within specifications. The batch record (b)(4) was verified and found it within specifications. Unomedical preliminary clinical evaluation: the patient suffered from frequent low blood glucose levels in the morning and therefore basal rate was adjusted. Patient went in to diabetic coma due to low blood glucose level. Spouse informed patient had trouble eating when spouse left for work. Spouse reported patient died from low blood glucose level. The pump history showed patient did not bolus for two days. No information exists regarding any manuel injection. There is no indication of infusion set malfunction. Unomedical is seeking further information on this case and expect to submit a follow-up mdr not later than 30-jun-2016.
 
Event Description
(b)(4). A (b)(6) male diabetic patient is receiving insulin treatment via a tandem insulin pump and an inset infusion set. According to the sister, the patient woke up in the morning of (b)(6) 2016 with low blood glucose at 51 mg/dl and had trouble eating. Later same day the patient died. Cause of death was reportedly low blood glucose leading to coma and subsequent death. The reporter stated that pump and infusion set was functioning as intended. The pumps basal rate had recently been reduced due to previous episodes of patient waking up with low blood glucose values. Unomedical is actively seeking further information on this case, which was reported to us by our customer and distributor (b)(4).
 
Manufacturer Narrative
The lot reference samples were tested for visual to the adhesive tape, flow, leak, needle, click and serter tests. All tests were found within specifications. The batch record 5119231 was verified and found it within specifications. Unomedical clinical evaluation: the patient suffered from frequent low blood glucose levels in the morning and therefore basal rate was adjusted. Patient went into diabetic coma due to low blood glucose level. Spouse informed patient had trouble eating when spouse left for work. Spouse reported patient died from low blood glucose level. The pump history showed patient did not bolus for two days. No information exists regarding any manual injection. There is no indication of infusion set malfunction. Unomedical conclusion: based on the investigation and test results (of lot reference samples) the claimed failure can not be confirmed. If new information becomes available the complaint will be re-opened and appropriate actions will be taken.
 
Event Description
(b)(4). A (b)(6)-year old male diabetic patient is receiving insulin treatment via a tandem insulin pump and an inset infusion set. According to the sister, the patient woke up in the morning of (b)(6) 2016 with low blood glucose at 51 mg/dl and had trouble eating. Later same day the patient died. Cause of death was reportedly low blood glucose leading to coma and subsequent death. The reporter stated that pump and infusion set was functioning as intended. The pumps basal rate had recently been reduced due to previous episodes of patient waking up with low blood glucose values. New since initial report: tandem is trying to get an anonymized copy of the death certificate. (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINSET INFUSION SET
Type of DeviceINSET 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 Key5684570
MDR Text Key46070848
Report Number3003442380-2016-00009
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,Followup
Report Date 06/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Model Number100-183-00
Device Lot Number5119231
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2015
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: 05/27/2016 Patient Sequence Number: 1
-
-