MAUDE Adverse Event Report: UNOMEDICAL UNOMEDICAL INFUSION SET, UNKNOWN MODEL NUMBER

Model Number UNKNOWN

Device Problem No Apparent Adverse Event (3189)

Patient Problems Death (1802); Hypoglycemia (1912); Coma (2417)

Event Date 03/31/2016

Event Type  Death  

Manufacturer Narrative

On 15-ju1-2016: unomedical is actively seeking further information on the incident.Unomedical is expected to submit a follow up (or final) emdr report not later than 15-aug-2016.

Event Description

(b)(4).The sister reported death of her diabetic brother on pump therapy at icu/(b)(6) hospital on (b)(6)2016.Customer was sleeping through the night which was abnormal due to his neuropathy an usual pain.Customer was then unable to be woken up.His blood glucose were 19 mg/dl and the reservoir had no more insulin left when ems arrived and customer was in a coma and was hospitalized on (b)(6) 2016 and then passed on (b)(6) 2016.Diagnosis or official cause of death was hypoglycemia.The sister feels the pump is the cause of death.Has not reported any lot number nor model number of the infusion set used.No further information available.

Manufacturer Narrative

On 15-aug-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.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.Unomedical is actively seeking further information on the incident.Unomedical is expected to submit a follow up (or final) emdr report not later than 15-sep-2016.

Event Description

(b)(4).The sister reported death of her diabetic brother on pump therapy at icu/(b)(6) on (b)(6) 2016.Customer was sleeping through the night which was abnormal due to his neuropathy an usual pain.Customer was then unable to be woken up.His blood glucose were 19 mg/dl and the reservoir had no more insulin left when ems arrived and customer was in a coma and was hospitalized on (b)(6) 2016 and then passed on (b)(6) 2016.Diagnosis or official cause of death was hypoglycemia.The sister feels the pump is the cause of death.Has not reported any lot number nor model number of the infusion set used.No further information available.

Manufacturer Narrative

On 16-sep-16 clinical evaluation: the spouse of patient reported patient passed away due to hypoglycemia.Patient was found in a coma and was taken to hospital.Patient was hospitalized (b)(6) 2016.Patient passed away (b)(6) 2016.Pump history is not known and there is nothing in the complaint description indicating set malfunction.The spouse of patient reported blood glucose level was down to 19 mg/dl and reservoir was empty indicating overdose of insulin.Chain of event is not clear.More information is necessary to perform a clinical evaluation.On 15-aug-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.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

(b)(4).The sister reported death of her diabetic brother on pump therapy at icu/(b)(4) on (b)(6) 2016.Customer was sleeping through the night which was abnormal due to his neuropathy an usual pain.Customer was then unable to be woken up.His blood glucose were 19 mg/dl and the reservoir had no more insulin left when ems arrived and customer was in a coma and was hospitalized on (b)(6) 2016 and then passed on (b)(6) 2016.Diagnosis or official cause of death was hypoglycemia.The sister feels the pump is the cause of death.Has not reported any lot number nor model number of the infusion set used.No further information available.

• Brand Name: UNOMEDICAL INFUSION SET, UNKNOWN MODEL NUMBER
• Type of Device: INFUSION SET
• Manufacturer (Section D): UNOMEDICAL; 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: 5797762
• MDR Text Key: 49627910
• Report Number: 3003442380-2016-00012
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Death