MAUDE Adverse Event Report: UNOMEDICAL A/S INFUSION SET - BRAND NAME UNKNOWN; INFUSION SET - DEVICE NAME UNKNOWN

Model Number UNKNOWN

Device Problem Material Deformation (2976)

Patient Problem Coma (2417)

Event Type  Injury  

Manufacturer Narrative

On 10-feb-2016: unomedical consider this an initial mdr report.No sample returned for investigation at this time.Since the device name and lot number is unknown at this time no relevant testing could be performed.More information is necessary to clinically evaluate and investigate this incident.Unomedical is currently investigating if more information could be retrieved for this incident.

Event Description

Unomedical reference number: (b)(4).A female diabetic patient reported to medtronic that she 5-6 years ago experienced the infusion set (no specific brand/device name reported) got pinched and she went into diabetic coma.The blood glucose level prior to the incident was out of range (no specific readings reported).No details about for how long the patient had been wearing the infusion set nor how the patient was wearing the infusion set at time of incident was reported.No details about treatment in hospital and length of stay was reported or medical history was reported.No details about when the patient restarted pump therapy was reported.No further information available.

Manufacturer Narrative

Feb.29, 2016: 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: the patient reported the infusion set got pinched.No other information is available.If the tubing gets pinch no insulin will flow through the tubing which will build up a pressure and when recognized by the pump which will give an alarm.The term diabetic coma is used if diabetic patient experience either low blood glucose level or high blood glucose level that causes unconsciousness.Even though not many information available this event is likely due to inadequate amount of insulin delivery and elevated blood glucose level.Not enough information to perform a clinical evaluation.No clinical consequences is reported due to this event.Feb.10, 2016: unomedical consider this an initial mdr report.No sample returned for investigation at this time.Since the device name and lot number is unknown at this time no relevant testing could be performed.More information is necessary to clinically evaluate and investigate this incident.Unomedical is currently investigating if more information could be retrieved for this incident.

Event Description

(b)(4).A female diabetic patient reported to medtronic that she 5-6 years ago experienced the infusion set (no specific brand/device name reported) got pinched and she went into diabetic coma.The blood glucose level prior to the incident was out of range (no specific readings reported).No details about for how long the patient had been wearing the infusion set nor how the patient was wearing the infusion set at time of incident was reported.No details about treatment in hospital and length of stay was reported or medical history was reported.No details about when the patient restarted pump therapy was reported.No further information available.

• Brand Name: INFUSION SET - BRAND NAME UNKNOWN
• Type of Device: INFUSION SET - DEVICE NAME UNKNOWN
• 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: 5429856
• MDR Text Key: 37963219
• Report Number: 3003442380-2016-00002
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 02/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Life Threatening