MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM 9500-27 STS-MC-001 manufactured by Dexcom, Inc..
[187204176]
(b)(4). Diabetes mellitus is a known cause of diabetic ketoacidosis.
Patient Sequence No: 1, Text Type: N, H10
[187204177]
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 upper buttocks on (b)(6) 2020. On (b)(6) 2020, the patient's cgm was 283 mg/dl but his bg was 472. Two days later, (b)(6) 2020, on the same sensor session, the patient? S cgm was 237 and his bg was 254? 278 mg/dl. The patient developed ketones because his bg was above 250 mg/dl for 3-4 hours; however, the cgm was below 250 mg/dl. He was taken to the hospital and was admitted for 4? 5 days. Data was evaluated and the allegation was undetermined. The probable cause could not be determined via data. The reported glucose values fall within the b zone of the parkes error grid. The data investigation did not find blood glucose calibration values to compare to cgm values during the reported sensor session or the calibrations during the reported sensor session were in accurate range per device specifications. No additional patient or event information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2020-030993 |
| MDR Report Key | 9907837 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-04 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2019-08-20 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS ASHLEY SPOTO |
| Manufacturer Street | 6340 SEQUENCE DR. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582000200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | PQF |
| Date Received | 2020-03-31 |
| Model Number | 9500-27 |
| Catalog Number | STS-MC-001 |
| Lot Number | 7258108 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM, INC. |
| Manufacturer Address | 6340 SEQUENCE DR. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-03-31 |