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

Model Number MMT-397

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 10/03/2017

Event Type  Death  

Manufacturer Narrative

The three lots mentioned are all affected by the medtronic global recall fa-784 which was announced/launched on 11-sep-2017 (i.E.3+ weeks earlier than the reported fatal accident.We do try to obtain further information on this fatal incident.Should we receive new, relevant information we will re-open and update this case and provide fda with a follow-up mdr.

Event Description

Unomedical reference (b)(4).The patient's mother reported that her (b)(6) diabetic son died immediately on impact in a vehicular accident.Blood glucose level at time of incident is not known.Patient was wearing his insulin pump at time of the accident.Mother noticed afterwards that her son had three empty boxes of infusion sets with lot numbers included in the medtronic recall fa-784, but states that she does not attribute the passing to this product recall since the customer had not changed the infusion set at the day of his fatal accident.Download of the pump's internal memory showed recent episodes of high blood glucose for several days prior to the accident.Mother further informs that her son some 12 years earlier (prior to beginning pump therapy) had suffered an episode of manifest hypoglycemia rendering him in diabetic coma for five weeks.In the past 18 months the patient had suffered several episodes of low blood glucose.

• Brand Name: QUICK-SET PARADIGM
• Type of Device: INSULIN INFUSION SET
• 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 Key: 7074554
• MDR Text Key: 93450337
• Report Number: 3003442380-2017-00020
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-397
• Device Lot Number: ONE OF 5143600 5171609 5097197
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 51 YR
• Patient Weight: 68