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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-551NAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-551NAH
Device Problems Break (1069); Crack (1135); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/17/2018
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 that their insulin pump was damaged. The customer¿s blood glucose level was 132 mg/dl. The customer states she was swimming and had a little crack on near the reservoir ring, went to put a new reservoir in it and when she unscrewed the reservoir rim cracked off and the o ring came out. Troubleshooting was performed for damage and noticed the reservoir was loose. Advised the pump will need to be replaced. Advised to discontinue use of the pump and revert to a back-up plan. The insulin pump will be returned for analysis.
 
Manufacturer Narrative
Insulin pump received with broken reservoir tube lip and missing reservoir tube o ring. A test reservoir was installed and did not lock in place due to complete broken reservoir tube lip.
 
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Brand Name530G INSULIN PUMP MMT-551NAH
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 Key7376669
MDR Text Key103804118
Report Number3004209178-2018-60268
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 09/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-551NAH
Device Catalogue NumberMMT-551NAH
Device Lot NumberA4551NAHJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2018
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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