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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-751NAL; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAL; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAL
Device Problems Fluid/Blood Leak (1250); Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/02/2018
Event Type  malfunction  
Manufacturer Narrative
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 insulin pump alarmed compromised force sensor system.The customer¿s blood glucose level was 91 mg/dl at the time of the incident.Customer stated that insulin was "squirting out" during the manual prime process.The customer stated that the drive support cap was loose.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will be returned for analysis.
 
Manufacturer Narrative
Pump passed the displacement test.Unit received with motor error alarm during the basic occlusion test due to loose/flush drive support disk.Unable to perform prime/delivery test, excessive no delivery test and occlusion test or verify the compromised force sensor alarm due to motor error alarm.
 
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Brand Name
530G INSULIN PUMP MMT-751NAL
Type of Device
ARTIFICIAL 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 Key7655441
MDR Text Key113167880
Report Number3004209178-2018-86855
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00643169503694
UDI-Public(01)00643169503694
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 Other
Type of Report Initial,Followup
Report Date 09/11/2018
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-751NAL
Device Catalogue NumberMMT-751NAL
Device Lot NumberA4751NALJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/02/2018
Initial Date FDA Received07/02/2018
Supplement Dates Manufacturer Received08/15/2018
Supplement Dates FDA Received09/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age37 YR
Patient Weight225
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