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U.S. Department of Health and Human Services

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

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UNOMEDICAL A/S MEDTRONIC INFUSION SET OF UNKNOWN BRAND AND MODEL INSULIN INFUSION SET Back to Search Results
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.
 
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Brand NameMEDTRONIC INFUSION SET OF UNKNOWN BRAND AND MODEL
Type of DeviceINSULIN 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 Key6363714
MDR Text Key68465447
Report Number8021545-2017-00003
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
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 Received02/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2017
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 Treatment Data
Date Received: 02/28/2017 Patient Sequence Number: 1
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