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

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.

• Brand Name: QUICK-SET PARADIGM
• Type of Device: QUICK-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 Key: 7112001
• MDR Text Key: 94636790
• Report Number: 3003442380-2017-00029
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006416
• UDI-Public: 05705244006416
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2020
• Device Model Number: MMT-397
• Device Lot Number: 5143605
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening