MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC INFUSION SET OF UNKNOWN BRAND AND MODEL; INSULIN INFUSION SET

Model Number UNKNOWN

Device Problem Bent (1059)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

Patient reports this incident 10 months after it occurred.Incident information is scarce, but it has not been possible to obtain more information.We cannot evaluate whether or not a bent soft cannula is the root cause.If insulin flow is blocked (by e.G.A bent cannula) the insulin pump will issue a 'no delivery' alarm (audible and visible).No relevant testing could be performed.If lot information had been available, the batch records and the complaint database would have been 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).A female diabetic patient is treated with insulin via a medtronic pump and a medtronic infusion set (set type and lot number are both unknown).In (b)(6) 2017 the patient reported that in (b)(6) 2016, she experienced elevated blood glucose level (600 mg/dl), hyperventilating and going into diabetic coma.Patient was admitted to (b)(6) hospital for 4 days and treated with iv fluids due to dehydration.Patient did not report any long-term clinical consequences due to this event.Patient allege that health care professional had stated, that a bent soft cannula was the cause of the event.There is no information if patient tried and succeeded in lowering glucose level by bolus or if other actions were applied by patient to self-treat the high blood glucose level.There is no information to whether patient received any pump alarms indicating interrupted flow.If bent cannula had resulted in interrupted flow, the pump is designed to give an alarm to indicate this.No used infusion set are returned for testing; the set type and the lot number are both unknown, so reference samples cannot be tested.If new information becomes available this case will be reevaluated.

• Brand Name: MEDTRONIC INFUSION SET OF UNKNOWN BRAND AND MODEL
• Type of Device: INSULIN INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, DK 42 30; DA DK 4230
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, DK-42 30; DA DK-4230
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, DK-42-30 ; 548670000
• MDR Report Key: 6363714
• MDR Text Key: 68465447
• Report Number: 8021545-2017-00003
• 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
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• 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
• Date Manufacturer Received: 01/10/2017
• 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): Hospitalization; Life Threatening