• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR CGM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR CGM Back to Search Results
Model Number MMT-UNK
Device Problem Failure to Deliver (2338)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2014
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. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge. Note: this is a remediation mdr. Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6) 2014. Subsequently, medtronic diabetes conducted a one year retrospective review of complaints. This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.
 
Event Description
The customer reported via phone call that they received no delivery alarm. Blood glucose at the time of incident was 79mg/dl. The customer was advised they may have to change the set and reservoir in order to troubleshoot. The customer was asked to disconnect and reconnect the reservoir. Then verify if connection is secure and push insulin using plunger. The customer declined to troubleshoot. It is uncertain if the insulin was able to exit the reservoir. Troubleshooting was not able to resolve the issue. The device will not be returned for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESERVOIR
Type of DeviceCGM
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer Contact
gerwin de graaff
18000 devonshire street
northridge, CA 91325-1219
8185764805
MDR Report Key5961639
MDR Text Key55328304
Report Number3004209178-2016-76715
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 04/13/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-UNK
Device Catalogue NumberMMT-UNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2014
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

-
-