630G INSULIN PUMP MMT-1715KL 630G

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for 630G INSULIN PUMP MMT-1715KL 630G manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[186526964] Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[186526965] The customer reported via phone call that the customer visit to emergency room and then was hospitalized due to diabetes ketoacidosis on (b)(6) 2020. Customer? S blood glucose value was 500 mg/dl. Customer had a symptom like headache and agitated. Customer was treated with intravenous fluid and insulin drip during hospitalization. The device will not return for the analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-92475
MDR Report Key9908888
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-20
Date Mfgr Received2020-03-20
Device Manufacturer Date2019-05-02
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactGERWIN DE GRAAFF
Manufacturer StreetCEIBA NORTE IND. PARK #50 ROAD
Manufacturer CityJUNCOS 00777-386
Manufacturer Country*
Manufacturer Postal00777-3869
Manufacturer Phone8185464805
Manufacturer G1MEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer StreetCEIBA NORTE IND. PARK #50 ROAD
Manufacturer CityJUNCOS 00777-386
Manufacturer Country*
Manufacturer Postal Code00777-3869
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name630G INSULIN PUMP MMT-1715KL 630G
Generic NameARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Product CodeOZO
Date Received2020-03-31
Model NumberMMT-1715KL
Catalog NumberMMT-1715KL
Lot NumberHG3D814
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer AddressCEIBA NORTE IND. PARK #50 ROAD JUNCOS 00777-386 * 00777-3869


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-31

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