MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-723LNAB

Device Problems Crack (1135); Device Dislodged or Dislocated (2923)

Patient Problem Hyperglycemia (1905)

Event Date 04/06/2017

Event Type  Injury  

Manufacturer Narrative

The insulin pump was received with cracked and bleeding lcd glass.The insulin pump had minor scratched lcd window, cracked battery tube threads, cracked reservoir tube lip, display window missing and end cap broken off.Analysis was unable to performed functional test due to display anomaly.

Event Description

The customer reported via phone call that the lcd screen came out of the insulin pump completely.The customer reported that the insulin pump was hit.The customer reported that the insulin pump was cracked open.The customer stated that they had high blood glucose over 600 mg/dl at the time of incident.The customer was advised that the insulin pump will need to be replaced.The customer was advised to disconnect from the insulin pump and revert to back-up plan.The insulin pump was returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• 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 Key: 6550535
• MDR Text Key: 74583245
• Report Number: 3004209178-2017-78048
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: P980022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723LNAB
• Device Catalogue Number: MMT-723LNAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 05/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 YR
• Patient Weight: 54