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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 3ML MMT-332A; PUMP, INFUSION
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MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 3ML MMT-332A; PUMP, INFUSION Back to Search Results
Model Number MMT-332A
Medical Device Problem Codes Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code Hyperglycemia (1905)
Date of Event 07/29/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
 
Event or Problem Description
It was reported that they had a high blood glucose value of 500 mg/dl and customer alleging possible insulin pump under delivery.The customer was treated with bolus.Customer had been using insulin pump system within 48 hours of reported high blood glucose.The customer was not using auto mode feature.The device will not be returned for analysis.
 
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Brand Name
RESERVOIR 3ML MMT-332A
Common Device Name
PUMP, INFUSION
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
*  00777-3869
MDR Report Key10366064
Report Number2032227-2020-157674
Device Sequence Number11612737
Product Code FRN
UDI-Device Identifier20763000273358
UDI-Public(01)20763000273358(17)230521(10)HG4BTNE
Combination Product (Y/N)N
Initial Reporter CountryPL
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date05/21/2023
Device Model NumberMMT-332A
Device Catalogue NumberMMT-332A
Device Lot NumberHG4BTNE
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/29/2020
Initial Report FDA Received Date08/05/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
UNOMED-INF SET
Outcome Attributed to Adverse Event Other;
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