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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-751LNAP ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAP ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751LNAP
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2017
Event Type  malfunction  
Manufacturer Narrative
Insulin pump received with cracked and bleeding lcd glass. Cracked case at the display window corners, cracked lcd window, cracked belt clip slot, cracked battery tube threads, missing end cap sticker, stained address/serial number label and cracked reservoir tube lip.
 
Event Description
The customer reported via phone call that their insulin pump was damaged when it fell and hit the concrete. Customer stated the screen had cracks. The customer¿s blood glucose level was 125 mg/dl at the time of the incident. The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan. The insulin pump was returned for analysis.
 
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Brand Name530G INSULIN PUMP MMT-751LNAP
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 Key7706034
MDR Text Key114741128
Report Number3004209178-2018-94384
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
Type of Report Initial
Report Date 07/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-751LNAP
Device Catalogue NumberMMT-751LNAP
Device Lot NumberA4751LNAPJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2018
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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