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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 No Apparent Adverse Event (3189)
Patient Problem Death (1802)
Event Date 08/29/2016
Event Type  Death  
Manufacturer Narrative
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. 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 son of deceased patient were not willing to report cause of dead or any other information regarding possible pump malfunction, infusion set malfunction or user error. The son reported that patient was wearing the pump at time of death. The son is not willing to send back pump and used infusion set for testing.
 
Event Description
(b)(4). Son of female diabetic patient reported that the patient passed away on (b)(6) 2016. The patient was on pump therapy and was wearing the pump and infusionset at the time of passing away. Son states that he only can provide some information due to legal reasons. Official cause of death was not reported. Blood glucose level at time of incident was also not provided. The doctors name is (b)(6). No further information available.
 
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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
548167000
MDR Report Key6321256
MDR Text Key67077100
Report Number3003442380-2017-00002
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 02/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2017
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 Received02/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/10/2017 Patient Sequence Number: 1
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