MAUDE Adverse Event Report: UNOMEDICAL A/S INFUSION SET, BRAND NAME UNKNOWN

Model Number UNKNOWN

Device Problem No Apparent Adverse Event (3189)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Coma (2417)

Event Type  Injury  

Manufacturer Narrative

On 25-nov-2016: 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. Unomedical is actively seeking further information on the incident.

Event Description

(b)(4). A diabetic female patient on pump therapy experienced diabetic ketoacidosis (dka) with a blood glucose around 1400 mg/dl and was hospitalized. Time and date of hospitalization is unknown. Name of the hospital: (b)(6). The incident was leading to coma. No information about if patient was wearing pump at the time of hospitalization. No information about discharge date. The patient was out of work for 5 weeks. Infusion set brand name and lot number unknown. No further information available.

Manufacturer Narrative

On 28-dec-2016: 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. Clinical evaluation: patient reports that approximately 8 weeks prior to 09-nov-2016 she experienced very high blood glucose levels up to 1400 mg/dl together with diabetic ketoacidosis and coma which lead to hospitalization. Not enough solid data to provide a proper medical review. On 25-nov-2016: 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. Unomedical is actively seeking further information on the incident. Unomedical is expected to submit a follow up (or final) emdr report not later than 27-dec-2016.

Event Description

(b)(4). A diabetic female patient on pump therapy experienced diabetic ketoacidosis (dka) with a blood glucose around 1400 mg/dl and was hospitalized. Time and date of hospitalization is unknown. Name of the hospital: (b)(6). The incident was leading to coma. Patient unsure if she was wearing pump at the time of hospitalization. No information about discharge date. The patient was out of work for 5 weeks. Infusion set brand name and lot number unknown. No further information available.

• Brand Name: INFUSION SET, BRAND NAME UNKNOWN
• Type of Device: INFUSION SET, BRAND NAME 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 ; 548167000
• MDR Report Key: 6127235
• Report Number: 3003442380-2016-00018
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/10/2016
• 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 Outcome(s): Hospitalization; Life Threatening