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

Model Number	9500-66
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Diabetes mellitus is a known cause of hypoglycemia and loss of consciousness.
Event or Problem Description
It was reported that an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred.The sensor was inserted into the abdomen on (b)(6) 2021.The patient was lying in bed and became unconscious; he does not remember having any symptoms and does not recall much about the event.His cgm displayed 6.0 mmol/l at the time he lost consciousness.His daughter called for an ambulance and gave him a glycogen injection (presumed to mean glucagon) before emergency medical services (ems) arrived.The bg meter in the ambulance read 1.9 mmol/l.He stated that at the hospital his glucose level came back up and he was discharged the next day in good condition, but no hospital treatment information was provided.He does not recall the treatment given in the ambulance.At the time of report, the patient was doing okay.Data was evaluated and the allegation was confirmed.The probable cause could not be determined via data.No additional patient or event information is available.
Event or Problem Description
The reported glucose values fall within the d zone of the parkes error grid.The data investigation found a difference in values that fall within the b zone of the parkes error grid.
Additional Manufacturer Narrative
(b)(4).B5: describe event or problem - additional.H2: additional information.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• MDR Report Key: 11445169
• Report Number: 3004753838-2021-45150
• Device Sequence Number: 11641059
• Product Code: PQF
• UDI-Device Identifier: 00386270000019
• UDI-Public: 00386270000019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P120005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 9500-66
• Device Catalogue Number: STS-GF-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other