MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS

Model Number 9500-27

Device Problems Use of Device Problem (1670); Invalid Sensing (2293)

Patient Problem Seizures (2063)

Event Date 06/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2016 to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter that occurred on (b)(6) 2016.The sensor was inserted on 06/08/2016.Patient stated that her cgm was reading 321mg/dl and gave herself humalog insulin to counteract the high readings.Patient had a seizure which lead to the patient's husband giving the patient glucose tablets.The patient did not take a fingerstick reading before treating and based dosage off the cgm readings.Patient state that the event was due to the cgm's inaccuracies.At the time of contact, the patient was healthy and at home.No additional event or patient information was provided.The patient made treatment decisions based on cgm values.The dexcom g5 mobile continuous glucose monitoring system states: the dexcom g5 mobile cgm system does not replace your bg meter.When making treatment decisions, such as the amount of insulin you need, only use your bg value.Don't use the dexcom g5 mobile cgm system sensor glucose readings because readings can be different from your bg value.If sensor glucose readings are used in determining treatments, it could result in you missing a severe low or high glucose event.

• Brand Name: DEXCOM G5 MOBILE 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: 5788561
• MDR Text Key: 49361108
• Report Number: 3004753838-2016-38674
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)NI(17)NI
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ZQUIL
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 61