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U.S. Department of Health and Human Services

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

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UNOMEDICAL A/S QUICK SET PARADIGM QUICK-SET PCC Back to Search Results
Model Number MMT-397
Device Problem Insufficient Information (3190)
Patient Problems Hypoglycemia (1912); Coma (2417)
Event Date 10/26/2016
Event Type  Injury  
Manufacturer Narrative
(b)(6) 2019. 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.   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 the lot number is provided to investigate a potential origin of the product failure in the devices manufacturing traceability documents.
 
Event Description
Unomedical reference number 1(b)(6). The below event has been reported to unomedical as a legal case. On the (b)(6) 2016 a female diabetic patient had her insulin pump and was driving to(b)(6) from her home. Patients pump malfunctioned and unexpectedly administered the entire reservoir of insulin to patient while she was driving on highway (b)(6). Patient blacked out and crashed her vehicle on the highway. Patient suffered severe, debilitating injuries, including a hypoglycemic event, diabetic coma, multiple fractured vertebrae, and cracked teeth. No available case data indicate any causal relation between claimed event and any infusion set malfunction. No further information provided.
 
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Brand NameQUICK SET PARADIGM
Type of DeviceQUICK-SET PCC
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
MDR Report Key8476909
MDR Text Key140734270
Report Number3003442380-2019-00003
Device Sequence Number1
Product Code FPA
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 04/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-397
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2019
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: 04/03/2019 Patient Sequence Number: 1
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