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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-1712K
Device Problems Computer Software Problem (1112); Communication or Transmission Problem (2896)
Patient Problems Hypoglycemia (1912); Seizures (2063); Pregnancy (3193)
Event Date 05/19/2020
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.
 
Event Description
Information received by medtronic indicated that the insulin pump had multiple insulin pump error alarms.It was reported that the customer experienced low blood glucose.The blood glucose reading was 20 mg/dl on (b)(6) 2020.It was reported that the customer had several hypoglycemia and convulsed.The customer was treated with a glucagon injection.It was also reported that on (b)(6) 2020, the customer had another low blood glucose incident.The blood glucose reading was 16 mg/dl and they were hospitalized.The customer was treated with 4 injections of glucose and sent home.The insulin pump will not be returned for analysis.
 
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Brand Name
640G INSULIN PUMP MMT-1712K
Type of Device
PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
*  00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
*   00777-3869
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
*   00777-3869
8185464805
MDR Report Key10108513
MDR Text Key193288845
Report Number2032227-2020-125613
Device Sequence Number1
Product Code OYC
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-1712K
Device Catalogue NumberMMT-1712K
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/29/2020
Initial Date FDA Received06/02/2020
Date Device Manufactured08/16/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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