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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-551NAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-551NAL
Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)
Patient Problem Hyperglycemia (1905)
Event Date 03/07/2018
Event Type  malfunction  
Manufacturer Narrative
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 the insulin pump had a recurring motor error alarm. The customer¿s blood glucose level was 363 mg/dl at the time of the incident and declined high blood glucose troubleshooting. The customer stated that the drive support cap was normal and possible exposure to high magnetic fields. Customer reported a motor position encoder error. Customer also reported scratches on the insulin pump lcd screen and had a blank display issue. The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan. The insulin pump is being replaced and is expected to return for analysis.
 
Manufacturer Narrative
The insulin pump passed the operating currents measurement, self test, rewind test, basic occlusion test, prime test and displacement test. Pump was received with stuck motor error alarm loop during bolus delivery. The motor was tested outside of the device and passed. The motor may have had an intermittent failure that was not detected during our testing. Unable to perform the occlusion and no delivery test due to motor error alarm. Unable to confirm encoder signal out alarm due to erase history file. No blank display anomaly noted. No setting changing anomaly noted. The insulin pump had a broken reservoir tube lip, severely scratched display window, stained end cap sticker, stained address, serial number label and corroded battery tube.
 
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Brand Name530G INSULIN PUMP MMT-551NAL
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 Key7370493
MDR Text Key103773783
Report Number3004209178-2018-59750
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 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-551NAL
Device Catalogue NumberMMT-551NAL
Device Lot NumberA4551NALJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2018
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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