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

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).

• Brand Name: INSET INFUSION SET
• Type of Device: INSET 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: 5684570
• MDR Text Key: 46070848
• Report Number: 3003442380-2016-00009
• 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,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Model Number: 100-183-00
• Device Lot Number: 5119231
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• 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): Death
• Patient Age: 54 YR