FDA Adverse Event
Injury
Summary report: N
TELCARE BLOOD BLUCOSE MONITORING SYSTEM
MDR report key: 5061774
·
Received September 4, 2015
Report
- Report Number
- 3008514395-2015-00001
- Event Type
- Injury
- Date Received
- September 4, 2015
- Date of Event
- August 6, 2015
- Report Date
- September 3, 2015
- Manufacturer
- TELCARE INC.
- Product Code
- NBW
- PMA / PMN Number
- K110571
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
PATIENT INDICATED THAT ON (B)(6) 2015, HER GRANDDAUGHTER, (I.E., CAREGIVER) CAME TO THE PATIENT'S HOUSE AND FOUND HER LAYING ON THE FLOOR AND SHAKING. THE PATIENT INDICATED THAT HER GRANDDAUGHTER TOOK HER BLOOD GLUCOSE MEASUREMENT USING THE TELCARE BGM AT 6:20 A.M. AND REGISTERED A READING OF 68 MG/DL. THE CAREGIVER CALLED FOR AN AMBULANCE/EMT, WHICH ARRIVED APPROXIMATELY FIVE TO TEN MINUTES LATER. THE PATIENT INDICATED THAT SHE WAS TRANSPORTED IN THE AMBULANCE TO THE HOSPITAL AND THAT THE EMT STAFF TOOK HER BLOOD GLUCOSE MEASUREMENT OF 33 MG/DL, WITH THEIR BLOOD GLUCOSE METER, (NON-TELCARE), WHILE IN TRANSIT. THERE WAS NO DEATH OR PERMANENT IMPAIRMENT ASSOCIATED W/THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 590293 | TELCARE BLOOD BLUCOSE MONITORING SYSTEM | NBW | TELCARE INC. | ME0001/PTS0001 | A31S1401009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other |