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U.S. Department of Health and Human Services

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

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UNOMEDICAL A/S INFUSION SET - BRAND NAME UNKNOWN INFUSION SET - DEVICE NAME UNKNOWN Back to Search Results
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.
 
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Brand NameINFUSION SET - BRAND NAME UNKNOWN
Type of DeviceINFUSION 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 Key5429856
MDR Text Key37963219
Report Number3003442380-2016-00002
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received01/19/2016
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: 02/11/2016 Patient Sequence Number: 1
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