MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS

Model Number 9500-27

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

Patient Problems Hyperglycemia (1905); Blurred Vision (2137); Shaking/Tremors (2515); Abdominal Cramps (2543)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a know cause of hyperglycemia and its associated effects.

Event Description

Distributor representative contacted dexcom on 04/14/2016 to report patient experienced a hyperglycemic event on (b)(6) 2016.The patient was at work and had a blood glucose value of 469mg/dl.A co-worker took her to the hospital emergency room.The patient was feeling shaky, having stomach cramps, blurred vision, rapid heart rate and was hardly talking.The sensor was removed for a ct scan, x-ray and mri.They hooked the patient up to an iv with benadryl 50mg, pepcid 20mg, 8 units humalog, ativan 0.5 mg, morphine 4 mg, zofran 4 mg, plus another iv with just fluids.Patient left the hospital with a fingerstick value of 167mg/dl.The patient was at the hospital for approximately 6-6.5 hours.At the time of contact, patient was in good condition.No additional event or patient information was provided.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 5652187
• MDR Text Key: 45091538
• Report Number: 3004753838-2016-02963
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5203882(17)160921
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/21/2016
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5203882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 48 YR
• Patient Weight: 148