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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET PARADIGM QUICK-SET 110/9 PCC

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QUICK-SET PARADIGM QUICK-SET 110/9 PCC Back to Search Results
Model Number MMT-396
Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problem Hyperglycemia (1905)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. On (b)(6) 2020, it was reported that yesterday, while working outside, the infusion set's tubing broke at the tubing connector. Therefore, patient blood glucose level went to 435 mg/dl, which the patient treated with pump. The site location was patient's thigh and the pump was clipped to belt. Moreover, the infusion set had been used for two days. Reportedly, the infusions were stored, or used, in a place where they might have been exposed to extreme temperatures and humidity. There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body. At the time of this report, patient's blood glucose level was 225 mg/dl. No further information available.
 
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Brand NameQUICK-SET PARADIGM
Type of DeviceQUICK-SET 110/9 PCC
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key10118191
MDR Text Key194390109
Report Number3003442380-2020-00290
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2021
Device Model NumberMMT-396
Device Lot Number5242594
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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