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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAS
Device Problems Break (1069); Crack (1135); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Currently it is unknown whether or not the device may have caused or contributed to the event. The device has been returned, but not yet evaluated. 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 the line got caught up with the belt clip and accidentally rolled over the insulin pump with the car. The bottom of the insulin pump popped off and the screen was completely cracked. Customer's blood glucose level was 128 mg/dl. Customer was advised to discontinue use of the device and revert to a backup plan. The customer was advised that the device would be replaced and agreed to return the product for analysis.
 
Manufacturer Narrative
Findings: unit received with cracked and bleeding lcd, missing display lcd window cover, cracked battery tube threads, broken reservoir tube lip, cracked case at display window corners, cracked case, broken off end cap and missing motor.
 
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Brand Name530G INSULIN PUMP MMT-751NAS
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
MDR Report Key6836623
MDR Text Key84332541
Report Number2032227-2017-43539
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 Patient
Type of Report Initial,Followup
Report Date 11/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-751NAS
Device Catalogue NumberMMT-751NAS
Device Lot NumberA4751NASJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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