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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S QUICK-SET PARADIGM

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UNOMEDICAL A/S QUICK-SET PARADIGM Back to Search Results
Model Number MMT-397
Device Problem No Apparent Adverse Event (3189)
Patient Problems Hypoglycemia (1912); Coma (2417)
Event Date 04/05/2017
Event Type  Injury  
Manufacturer Narrative
The reference samples were visually inspected and tested for flow, leak and ventilation. All test results were within specifications. Ventilation test results: p1: 256. 0, p2: 256. 0, p3: 256. 0, p4: 256. 0, p5: 256. 0, p6: 256. 0, p7: 256. 0, p8: 256. 0, p9: 256. 0 & p10: 256. 0 the batch record # 5143605 was verified and it was 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. If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.
 
Event Description
(b)(4). On (b)(6) 2017 a diabetic male patient on pump therapy experienced hypoglycemia and consequently coma and was hospitalized ((b)(6) hospital). Blood glucose at time of hospitalization was 24 mg/dl. Cause of hospitalization per hcp was hypoglycemia. Patient was wearing pump at time of hospitalization. Patient was treated with glucose and glucagon shot at home before getting him to the er. The patient feels the incident occurred due to the infusion set, he did not know about the recall then but when he got the letter he realized it must have been due to the sets. No further information available.
 
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Brand NameQUICK-SET PARADIGM
Type of DeviceQUICK-SET PARADIGM
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
4548167000
MDR Report Key7112001
MDR Text Key94636790
Report Number3003442380-2017-00029
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244006416
UDI-Public05705244006416
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 12/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2020
Device Model NumberMMT-397
Device Lot Number5143605
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2016
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: 12/13/2017 Patient Sequence Number: 1
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