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U.S. Department of Health and Human Services

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

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UNOMEDICAL A/S INFUSION SET, BRAND NAME UNKNOWN Back to Search Results
Model Number UNKNOWN
Device Problem No Apparent Adverse Event (3189)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Coma (2417)
Event Type  Injury  
Manufacturer Narrative
On 25-nov-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.
 
Event Description
(b)(4). A diabetic female patient on pump therapy experienced diabetic ketoacidosis (dka) with a blood glucose around 1400 mg/dl and was hospitalized. Time and date of hospitalization is unknown. Name of the hospital: (b)(6). The incident was leading to coma. No information about if patient was wearing pump at the time of hospitalization. No information about discharge date. The patient was out of work for 5 weeks. Infusion set brand name and lot number unknown. No further information available.
 
Manufacturer Narrative
On 28-dec-2016: the claimed failure cannot be confirmed. The complaint has been reviewed based on the customer complaint description and evaluates that no further investigation can be performed before either used samples are received for testing or that the lot number is provided to investigate a potential origin of the product failure in the devices manufacturing traceability documents. Clinical evaluation: patient reports that approximately 8 weeks prior to 09-nov-2016 she experienced very high blood glucose levels up to 1400 mg/dl together with diabetic ketoacidosis and coma which lead to hospitalization. Not enough solid data to provide a proper medical review. On 25-nov-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 27-dec-2016.
 
Event Description
(b)(4). A diabetic female patient on pump therapy experienced diabetic ketoacidosis (dka) with a blood glucose around 1400 mg/dl and was hospitalized. Time and date of hospitalization is unknown. Name of the hospital: (b)(6). The incident was leading to coma. Patient unsure if she was wearing pump at the time of hospitalization. No information about discharge date. The patient was out of work for 5 weeks. Infusion set brand name and lot number unknown. No further information available.
 
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Brand NameINFUSION SET, BRAND NAME UNKNOWN
Type of DeviceINFUSION SET, BRAND 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 Key6127235
MDR Text Key60853627
Report Number3003442380-2016-00018
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 12/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2016
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 Received11/10/2016
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: 11/25/2016 Patient Sequence Number: 1
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