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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Hyperglycemia (1905); Hypoglycemia (1912); Weakness (2145); Anxiety (2328); Sweating (2444); Shaking/Tremors (2515)
Event Date 07/10/2020
Event Type  Injury  
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 experienced low blood glucose. Blood glucose reading was 40 mg/dl. Customer¿s other blood glucose values are 226 mg/dl. Customer was treated with food for their low. Customer had symptoms such as shaking, sweating, anxiety, mental confusion, weakness, and fatigue. The insulin pump will be returned for analysis.

 
Manufacturer Narrative

Device passed the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, sleep current measurement, active current measurement, self test and displacement accuracy test. A water filled reservoir was used during testing. Device was programmed with multiple boluses and monitored. All boluses delivered properly and were listed in the daily history. Device was programmed with multiple basal profiles and monitored. All basal profiles delivered their indicated amounts and were verified in the daily and summary history screens. No delivery anomaly, bolus anomaly or basal anomaly noted during testing. (b)(4).

 
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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 Key10281119
MDR Text Key199043543
Report Number2032227-2020-147176
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 08/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-1715KM
Device Catalogue NumberMMT-1715KM
Device LOT NumberHG1KX9Q
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/22/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/03/2017
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: 07/15/2020 Patient Sequence Number: 1
Treatment
FRN-MMT-332-RSVR, UNOMED INF SET
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