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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715K
Device Problems Obstruction of Flow (2423); No Apparent Adverse Event (3189)
Patient Problems Bruise/Contusion (1754); Hematoma (1884); Complaint, Ill-Defined (2331); Blood Loss (2597)
Event Date 09/29/2020
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 were hospitalized for unknown reason on unknown date. Blood glucose reading was unknown. It was unknown that how the customer was treated at the hospital. Customer stated that insulin pump had insulin flow block alarm and customer was changed infusion set and reservoir, but issue was not resolved. The insulin pump will be returned for analysis.

 
Manufacturer Narrative

Device passed the functional tests, including the self test, sleep current measurement, active current measurement, rewind test, prime or seating test, basic occlusion test, occlusion test, force sensor test, displacement test and delivery accuracy test at 0. 08720 inches. No unexpected insulin flow blocked alarm noted. Device received with pillowing keypad overlay and cracked retainer. (b)(4).

 
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Brand Name630G INSULIN PUMP MMT-1715K 630G BLACK MG
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 Key10647142
MDR Text Key210358669
Report Number2032227-2020-187998
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 11/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device LOT NumberHG1E967
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/12/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/13/2016
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: 10/08/2020 Patient Sequence Number: 1
Treatment
FRN-MMT-326-RSVR, UNOMED SET.
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