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

Model Number MMT-399

Device Problems Kinked (1339); Manufacturing, Packaging or Shipping Problem (2975); No Apparent Adverse Event (3189); Insufficient Information (3190); Device Handling Problem (3265)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 09/04/2015

Event Type  Death  

Event Description

(b)(4).Patients wife reported that diabetic patient treated with insulin via a pump and infusion set.Experienced heart attack on (b)(6) 2015.The patient was hospitalized on (b)(6) 2015 to have surgery for heart attack and was taken off pump therapy with insulin due to surgery.The patient deceased 5 days after surgery on (b)(6) 2015 in the hospital.The patient had been off pump therapy 5 days before passing.Diagnosis or official cause of death was heart attack.Unomedical is investigating this case and trying to obtain further information.

Manufacturer Narrative

No relevant testing could be performed.If lot information was available, the batch records and the complaint database were reviewed for relevant deviations and similar complaints.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.Clinical evaluation: patient's wife reported that patient past away after surgery because of a heart attack.There is no information available about what happened prior to hospitalization.It is reported that patient's blood glucose at time of hospitalization was 600 mg/dl.There is not reported any symptoms that indicates that patient was suffering from diabetic ketoacidosis.There is not reported any damage to infusion set and pump history is not providing any additional information of what might have caused the elevated blood glucose.Patient's infusion set was removed at time of hospitalization by a health care professional because of surgery.Patient did not wear the infusion set again before passing away 5 days after surgery.

Event Description

(b)(4).Patients wife reported that diabetic patient treated with insulin via a pump and infusion set.Experienced heart attack on (b)(6) 2015.The patient was hospitalized on (b)(6) 2015 to have surgery for heart attack and was taken off pump therapy with insulin due to surgery.Patient's infusion set was removed at time of hospitalization by a health care professionals.It is reported that patient's blood glucose at time of hospitalization was 600 mg/dl.The patient deceased 5 days after surgery on (b)(6) 2015 in the hospital.The patient had been off pump therapy 5 days before passing.Diagnosis or official cause of death was heart attack.No further information available.

Manufacturer Narrative

Additional information 01/19/2016: used tubing sample received for this incident.A visual inspection and a test for flow, ventilation and leak were performed on the returned used device.The tubing had kink marks.Damages to the tubing can occur during several steps in manufacturing.To prevent systematic failures during manufacturing, unomedical uses online sampling plans according to iso 2859-1.Sample sizes are tested against specifications.During use the patient could also accidentally kink the tubing by winding it or getting the tubing caught on or in something.Clinical evaluation: patient's wife reported that patient passed away after surgery because of a heart attack.There is no information available about what happened prior to hospitalization.It is reported that patient's blood glucose at time of hospitalization was 600 mg/dl.There is not reported any symptoms that indicates that patient was suffering from diabetic ketoacidosis.There is not reported any damage to infusion set and pump history is not providing any additional information of what might have caused the elevated blood glucose.Patient's infusion set was removed at time of hospitalization by a health care professional because of surgery.Patient did not wear the infusion set again before passing away 5 days after surgery.

Event Description

(b)(4).Patients wife reported that diabetic patient treated with insulin via a pump and infusion set.Experienced heart attack on (b)(6) 2015.The patient was hospitalized on (b)(6) 2015 to have surgery for heart attack and was taken off pump therapy with insulin due to surgery.Patient's infusion set was removed at time of hospitalization by a health care professionals.It is reported that patient's blood glucose at time of hospitalization was 600 mg/dl.The patient died 5 days after surgery on (b)(6) 2015 in the hospital.The patient had been off pump therapy 5 days before passing.Diagnosis or official cause of death was heart attack.No further information available.

• Brand Name: QUICK SET PARADIGM
• Type of Device: QUICK-SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320 ; 548167000
• MDR Report Key: 5219374
• MDR Text Key: 30972050
• Report Number: 3003442380-2015-00017
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-399
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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; Hospitalization