RESERVOIR 3ML MMT-332A

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 RESERVOIR 3ML MMT-332A manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[185916519] 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.
Patient Sequence No: 1, Text Type: N, H10


[185916520] Customer reported via phone call that they were hospitalized due to high blood glucose level and on (b)(6) 2020 with 900 mg/dl blood glucose value. The customer also mentioned blood glucose level of over 600 mg/dl and 536 mg/dl. The customer was treated with intravenous drip, pen and insulin pump. Customer did not report symptoms related high blood glucose level. Customer did allege insulin pump as under delivering. Drive support cap was normal. It was unknown whether the customer was using auto mode or not. Troubleshooting was declined by the customer for high blood glucose. The device will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-92396
MDR Report Key9908299
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-22
Date Mfgr Received2020-03-22
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 NameRESERVOIR 3ML MMT-332A
Generic NamePUMP, INFUSION
Product CodeFRN
Date Received2020-03-31
Model NumberMMT-332A
Catalog NumberMMT-332A
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.