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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KM
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); No Code Available (3191)
Event Date 08/26/2020
Event Type  Malfunction  
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. 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.

 
Event Description

The customer reported via phone call that they believe the pump is malfunctioning. The customer constantly treated they high blood glucose levels. The customer felt sleepy and decided to rest. The customer stated they became unresponsive from their low blood glucose and the customer¿s husband called 911. Blood glucose reading 49 mg/dl. The customer was hospitalized for low blood glucose. Customer was admitted to the emergency room on (b)(6) 2020 for an unknown period of time. Blood glucose reading was below 20 mg/dl at the time of admission to the emergency room. Customer was treated with iv insulin drip. The user alleged the insulin pump was over delivering insulin due to customer alleging pump says malfunctioned since they started having high blood glucose levels and thought the pump delivered too much insulin. The customer also mentioned that the pump had been exposed to strong magnetic fields when they had an x-ray. The date of the x-ray exposure was unknown but was months ago. Customer has been using insulin pump system within 48 hours of reported low blood glucose. The customer¿s blood glucose at the time of the call was 129 mg/dl. The insulin pump will be returned for analysis.

 
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Brand NamePUMP MMT-1715KM 630G 3ML BLACK MEDI
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
8185464805
MDR Report Key10486600
MDR Text Key205456676
Report Number2032227-2020-171464
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-1715KM
Device Catalogue NumberMMT-1715KM
Device LOT NumberHG2F92Q
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/14/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/03/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/03/2020 Patient Sequence Number: 1
Treatment
FRN-MMT-332-RSVRUNOMED INF SET
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