630G INSULIN PUMP MMT-1715K 630G BLACK MG

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-1715K 630G BLACK MG manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[185948932] Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
Patient Sequence No: 1, Text Type: N, H10


[185948933] The customer reported mechanical issue error via phone call. Customer blood glucose reading was 224 mg/dl. Troubleshooting was performed. The insulin pump was not exposed to magnetic field. Insulin pump will be returning for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-92449
MDR Report Key9908842
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-21
Date Mfgr Received2020-03-21
Device Manufacturer Date2018-01-22
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-1715K 630G BLACK MG
Generic NameARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Product CodeOZO
Date Received2020-03-31
Model NumberMMT-1715K
Catalog NumberMMT-1715K
Lot NumberHG29X3T
Device Expiration Date2018-07-26
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
10 2020-03-31

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