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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S UNOMEDICAL INFUSION SET, BRAND UNKNOWN (NOT REPORTED)

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UNOMEDICAL A/S UNOMEDICAL INFUSION SET, BRAND UNKNOWN (NOT REPORTED) Back to Search Results
Model Number UNKNOWN
Device Problem No Apparent Adverse Event (3189)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Coma (2417)
Event Date 09/07/2016
Event Type  Injury  
Manufacturer Narrative
On 29-sep-2016: 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. Unomedical is actively seeking further information on the incident. Unomedical is expected to submit a follow up (or final) emdr report not later that 31-oct-2016.
 
Event Description
(b)(4). A female diabetic patient reported that she is having some issues with her pump, patient stated that this is the second time that the pump does not alarm her. Reported that she ended up in a diabetic coma and her husband found her passed out on the floor back on (b)(6) 2016 and she was hospitalized. Blood glucose when admitted to hospital was over 500 mg/dl. Patient reported that she may have had a headache the day the incident occurred, but no other symptoms. The patient was wearing pump at the time of the hospitalization. Patient stated that her husband advised her that her infusion set was out, this could have been when she fell on the floor. The patient was treated with syringes. Name of hospital: (b)(6). Cause of hospitalization per hcp: high blood glucose, diabetic ketoacidosis (dka), coma. The patient was discharged on (b)(6) 2016. No further information available.
 
Manufacturer Narrative
On 04-nov-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 being concerned that the pump did not alarm as it was supposed to. The patient was to discuss issues with healthcare professional. Patient mentioned an earlier incident which already is reported by medtronic due to failure categorized as a pump issue. On 29-sep-2016: 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. Unomedical is actively seeking further information on the incident. Unomedical is expected to submit a follow up (or final) emdr report not later that 31-oct-2016.
 
Event Description
(b)(4). A female diabetic patient reported that she is having some issues with her pump, patient stated that this is the second time that the pump does not alarm her. Reported that she ended up in a diabetic coma and her husband found her passed out on the floor back on (b)(6) 2016 and she was hospitalized. Blood glucose when admitted to hospital was over 500 mg/dl. Patient reported that she may have had a headache the day the incident occurred, but no other symptoms. The patient was wearing pump at the time of the hospitalization. Patient stated that her husband advised her that her infusion set was out, this could have been when she fell on the floor. The patient was treated with syringes. Name of hospital: (b)(6). Cause of hospitalization per hcp: high blood glucose, diabetic ketoacidosis (dka), coma. The patient was discharged on (b)(6) 2016. No further information available.
 
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Brand NameUNOMEDICAL INFUSION SET, BRAND UNKNOWN (NOT REPORTED)
Type of DeviceINFUSION 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 Key5985944
MDR Text Key55873159
Report Number3003442380-2016-00015
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 11/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2016
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 Received09/13/2016
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: 09/29/2016 Patient Sequence Number: 1
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