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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S AC TENDER LL COMFORT

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UNOMEDICAL A/S AC TENDER LL COMFORT Back to Search Results
Model Number 4541502001
Device Problems Detachment Of Device Component (1104); Leak/Splash (1354)
Patient Problem Coma (2417)
Event Date 12/17/2016
Event Type  Injury  
Manufacturer Narrative
On 02/22/2017, the reference samples were visually inspected and tested for connector, click, flow, leak and static pull of tubing-tubing connector/luer lock connector. All test results were within specifications. Batch record (b)(4) was verified and found within specifications. The claimed failure cannot be confirmed. An investigation has been performed based on the customer complaint description and the reference samples from the same lot number. According to unomedical's traceability records, no relevant deviations were found. No used samples are available for further investigation. If new information becomes available, the complaint will be re-opened and appropriate actions will be taken. Clinical evaluation: the patient called to report that patient was admitted to the hospital due to high blood glucose level. Patient state that patient checked the blood glucose levels often, and continued to give boluses to bring down blood glucose level. Apart from giving bolus, the patient also began drinking water around, but still the blood glucose level did not come back down. Patient also did not eat anything all day since blood glucose was so elevated. The patient started to experience symptoms of vomiting, shakiness, and sensitivity to light. The next day patient was taken to the emergency room. The patient was unconscious after arriving to the er and did not regain consciousness until after 2-3 days. At hospital the patient was treated at the hospital with novolog insulin and iv fluids and in hospital they also found an esophageal thrush, which was also treated by medication at the hospital. The patient reported that the hospital was alleging that her pump wasn't delivering properly. The patient did not report any clinical consequences due to this event.
 
Event Description
Unomedical reference number (b)(4). Patient was admitted unconscious to hospital on (b)(6) 2016, due to her infusion set had accidentally disconnected between her tubing and the headset, which resulted in a high blood glucose level of 571 mg/dl. She had been trying to normalize her blood glucose level by bolusing through the pump, with no luck. She had started experiencing symptoms of diabetic ketoacidosis and was driven to the emergency room and then to the hospital while unconscious. Patient was treated at the hospital with novolog and iv fluids. Patient was released after treatment on the (b)(6) 2016.
 
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Brand NameAC TENDER LL
Type of DeviceCOMFORT
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 Key6348631
MDR Text Key67925065
Report Number8021545-2017-00001
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K162812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 02/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model Number4541502001
Device Lot Number5117150
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2015
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: 02/22/2017 Patient Sequence Number: 1
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