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

Model Number MMT-399

Device Problem Kinked (1339)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Loss of Vision (2139); Heart Failure (2206); Coma (2417); Multiple Organ Failure (3261)

Event Date 07/25/2014

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016: 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. Unomedical is actively seeking further information on the incident. Unomedical is expected to submit a follow up (or final) emdr report not later than (b)(6) 2016.

Event Description

(b)(4). A female diabetic patient reported she experienced high blood glucose and diabetic coma due to kinked infusion set and was hospitalized on (b)(6) 2014. The patient was admitted to hospital and in coma for 3 days and total time spent at the hospital was 10 days. The patient's blood glucose value was over 1000 mg/dl. The significant events leading to the hospitalization was that the site was kinked and the patient was physically exhausted. Due to the kinked site the patient did not get the insulin she needed. The patient was wearing the pump at the time of hospitalization, but the pump was removed from her within the first 2 hours. The infusion set was taken out at the hospital and noticed that the cannula was bent. Name of hospital: (b)(6) hospital, (b)(6). No symptoms stated by the patient. Consequences reported: kidney failure, heart failure, high blood glucose, low blood glucose and diabetic coma. The patient became legally blind after suffering from coma (permanent damage). No further information available.

Manufacturer Narrative

Update 28-sep-2016: the patient reported going in to diabetic coma due to high blood glucose level with multiple severe life-threatening complications (diabetic coma, kidney failure, heart failure). Patient was admitted to hospital for 10 days. As a clinical consequence of the event the patient had become legally blind. This event is being reported retrospectively due to patient is seeking advice on how to get patients insurance to pay for a continuous glucose monitor. The patient reports that in hospital the cannula was found bend upon removal at the hospital and that patient leading up to the event was physically exhausted. Bend soft cannula is a known risk and to mitigate the risk the pump has a build in feature that is to give an alarm if flow is interrupted. There is no information whether the pump gave an alarm indicating that flow of insulin due to bent cannula was interrupted. No used set is returned for tests. It has not been possible to get any information about the pump history (alarms would have been logged in the system). It is not possible to determine whether a combination of patient being physically exhausted and potential malfunction in pump mechanism or in infusion set is reason for patient experiencing this serious incident. If new information becomes available these will be evaluated. Update 27-sep-2016: no relevant testing could be performed because no samples were returned. Since the lot number is unknown, not batch record reviewing 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. Update 24-aug-2016: 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.

Event Description

(b)(4). A female diabetic patient reported she experienced high blood glucose and diabetic coma due to kinked infusion set and was hospitalized on (b)(6) 2014. The patient was admitted to hospital and in coma for 3 days and total time spent at the hospital was 10 days. The patient's blood glucose value was over 1000 mg/dl. The significant events leading to the hospitalization was that the site was kinked and the patient was physically exhausted. Due to the kinked site the patient did not get the insulin she needed. The patient was wearing the pump at the time of hospitalization, but the pump was removed from her within the first 2 hours. The infusion set was taken out at the hospital and noticed that the cannula was bent. Name of hospital: (b)(6). No symptoms stated by the patient. Consequences reported: kidney failure, heart failure, high blood glucose, low blood glucose and diabetic coma. The patient became legally blind after suffering from coma (permanent damage). No further information available.

Manufacturer Narrative

On 27-sep-2016: no relevant testing could be performed because no samples were returned. Since the lot number is unknown, not batch record reviewing 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 is actively seeking further information on the incident. Unomedical is expected to submit a follow up (or final) emdr report not later than 27-oct-2016. On 24-aug-2016: 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.

Event Description

(b)(4). A female diabetic patient reported she experienced high blood glucose and diabetic coma due to kinked infusion set and was hospitalized on (b)(6) 2014. The patient was admitted to hospital and in coma for 3 days and total time spent at the hospital was 10 days. The patient's blood glucose value was over 1000 mg/dl. The significant events leading to the hospitalization was that the site was kinked and the patient was physically exhausted. Due to the kinked site the patient did not get the insulin she needed. The patient was wearing the pump at the time of hospitalization, but the pump was removed from her within the first 2 hours. The infusion set was taken out at the hospital and noticed that the cannula was bent. Name of hospital: (b)(6). No symptoms stated by the patient. Consequences reported: kidney failure, heart failure, high blood glucose, low blood glucose and diabetic coma. The patient became legally blind after suffering from coma (permanent damage). No further information available.

• Brand Name: QUICK-SET PARADIGM
• Type of Device: QUICK - SET, INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320 ; 548167000
• MDR Report Key: 5899582
• MDR Text Key: 52833606
• Report Number: 3003442380-2016-00013
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-399
• Device Lot Number: UNKNOWN
• 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 Received: 06/03/2016
• 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: 08/24/2016 Patient Sequence Number: 1