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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-551LNAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551LNAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-551LNAH
Device Problems False Reading From Device Non-Compliance (1228); Insufficient Flow or Under Infusion (2182)
Patient Problem Hyperglycemia (1905)
Event Date 12/10/2017
Event Type  Injury  
Manufacturer Narrative
Device received with intermittent button response due to flattened (escape and act ) button dome switch (no crease) and partial unlocked lcd keypad connector noted during visual inspect. Unable to perform all functional testing including the displacement, operating currents, unexpected restart error test , rewind, basic occlusion, occlusion, prime or compromised force sensor system alarm and excessive no delivery test or verify under delivery anomaly due to buttons not responding. Device received with cracked battery tube threads, cracked lcd window, minor scratched lcd window, cracked reservoir tube lip, cracked case display window corner, cracked belt clip slot and cracked case reservoir tube window corner.
 
Manufacturer Narrative
This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4) site, per variance 5. 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 that the customer had high blood glucose level. The customer¿s blood glucose level was 300 mg/dl at the time of incident and current blood glucose level was 57 mg/dl. The customer was treated with manual injection for high blood glucose level. The customer¿s blood glucose level was around 300 mg/dl and 500 mg/dl, in the morning it was 599 mg/dl and went down to 96 mg/dl after injecting manual injection. The customer reported that she did not have any symptom related to high blood glucose level however, had stomach virus. The customer reported that the insulin pump was under delivering as the blood glucose level was not going down even after bolusing multiple times. The drive support cap was normal. The customer removed reservoir, rewound, reinserted reservoir and ran manual prime and filled tubing with current set and insulin exited. Customer was advised to discontinue use of the device and revert to a back-up plan. The customer was advised that the device would be replaced and agreed to return the insulin pump for analysis.
 
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Brand Name530G INSULIN PUMP MMT-551LNAH
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 Key7151736
MDR Text Key110610254
Report Number2032227-2017-77813
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 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-551LNAH
Device Catalogue NumberMMT-551LNAH
Device Lot NumberA4551LNAHJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2018
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

Patient Treatment Data
Date Received: 12/28/2017 Patient Sequence Number: 1
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