MAUDE Adverse Event Report: UNOMEDICAL A/S UNKNOWN

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hypoglycemia (1912)

Event Date 01/23/2018

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.The claimed failure cannot be confirmed.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 that 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 (b)(4).On (b)(6) 2018 a female diabetic patient on pump therapy experienced a hypoglycemic event.When husband went to check on her, she was not waking up.Later checked her blood glucose level and it had went down to 22 mg/dl.Husband mentioned that when going to the hospital on (b)(6) 2018 the hospital took off the pump because they were going to manage her bg levels and wanted off the pump.Patient passed away on (b)(6) 2018 at the hospital.Husband mentioned that she had brain swelling, low oxygen and low blood glucose.Since it has not been possible for unomedical to gather information about the product and lot number, we have decided to report this case.No further information provided.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• 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: 7649502
• MDR Text Key: 112692860
• Report Number: 3003442380-2018-00027
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• 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