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

Model Number MMT-522NAS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Reaction (2414)

Event Date 11/02/2016

Event Type  Injury  

Manufacturer Narrative

The insulin pump was received with currents in spec.The pump passed rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.The pump had minor scratched lcd window, cracked case near display window corners, cracked battery tube threads, cracked reservoir tube lip, reservoir tube cracked and missing end cap sticker, and cracked lcd window.

Event Description

Customer reported via phone call that they experienced low blood glucose levels of under 60 mg/dl.The customer was treated for the low blood glucose with injection shots.The customer's current blood glucose was 102 mg/dl.The customer stated that he was asleep and had a horrible insulin reaction.The customer was assisted with troubleshooting and stated that the drive support cap was normal.The product was returned for analysis.

• Brand Name: PARADIGM REAL-TIME 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: 6695891
• MDR Text Key: 79351677
• Report Number: 3004209178-2017-61912
• 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: 11/07/2016

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-522NAS
• Device Catalogue Number: MMT-522NAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 07/08/2017
• 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: 73 YR
• Patient Weight: 81