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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-551NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-551NAB
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2017
Event Type  malfunction  
Manufacturer Narrative
The insulin pump passed operating current, displacement test but the compromised force sensor system alarm occurred during the basic occlusion test due to loose/protruded drive support disk. Unable to perform the occlusion, prime/compromised force sensor system and excessive no delivery test or verify prime/fill anomaly and rewind anomaly due to compromised force sensor system alarm. The following physical damage was noted: cracked case at the display window corner, minor broken reservoir tube lip, minor scratched lcd window, missing end cap sticker, cracked case reservoir tube window corner and minor broken battery tube threads. No moisture damage on the lcd board, mother board, interface board, rf board, motor, vibrator motor and battery tube assembly during visual inspection noted.
 
Event Description
The customer's parent reported via phone call that they received compromised force sensor system alarm. The customer's blood glucose was 115 mg/dl at the time of incident. The caller reported that the insulin was squirting out during manual prime process. The insulin pump was returned for analysis.
 
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Brand Name530G INSULIN PUMP MMT-551NAB
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 Key7671990
MDR Text Key113628845
Report Number3004209178-2018-89376
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 07/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-551NAB
Device Catalogue NumberMMT-551NAB
Device Lot NumberA2551NABJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2017
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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