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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-551LNAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551LNAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-551LNAB
Device Problems Fluid Leak (1250); Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339); Device Displays Incorrect Message (2591)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
Event Date 08/09/2017
Event Type  Injury  
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
Customer¿s parent reported via phone call low blood glucose levels, high blood glucose levels and hospitalization. Customer blood glucose level went as low as 50 mg/dl and as high as 380 mg/dl. Customer experienced nausea, dehydration, pain in limbs, headache and they treated their high blood glucose via bolus delivery. Customer treated their low blood glucose levels via orange juice. Customer went to the hospital on (b)(6) 2017 at 12:00 pm. Customer current blood glucose level was 324 mg/dl. Customer¿s blood glucose went severely low because they accidentally delivered a bolus when they did not need it. Troubleshooting for compromised force sensor system was performed. Customer advised during the manual prime process insulin squirted out. Customer advised the drive support cap was normal. Customer advised during the seating of the force the sensor did not detect the reservoir. Customer was advised to discontinue use of the device and revert to a backup plan. Customer was advised that the device would be replaced and agreed to return the product for analysis.
 
Manufacturer Narrative
Findings: unit passed the dat test. All operating currents are within specification. No unexpected low battery or off no power alarms noted. Unit passed functional test including displacement test, rewind, basic occlusion, occlusion, prime, and excessive no delivery alarm test. No compromised forced sensor alarms or prime anomaly noted during testing. Unit functioned properly. Unit received with intermittent button response during testing due to flattened dome switch on the act button. Lcd connector was inspected and no anomaly was noted. Unit received with minor scratched lcd window and cracked reservoir tube lip. A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing. After testing it was concluded that the device operated within specifications.
 
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Brand Name530G INSULIN PUMP MMT-551LNAB
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 Key6835018
MDR Text Key84254625
Report Number2032227-2017-43222
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,other
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-551LNAB
Device Catalogue NumberMMT-551LNAB
Device Lot NumberA4551LNABJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2017
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

Patient Treatment Data
Date Received: 08/31/2017 Patient Sequence Number: 1
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