FDA Adverse Event
Injury
Summary report: N
INSULIN PUMP
MDR report key: 6141904
·
Received December 2, 2016
Report
- Report Number
- 3007981285-2016-22977
- Event Type
- Injury
- Date Received
- December 2, 2016
- Date of Event
- November 1, 2014
- Report Date
- November 10, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CORRECTION- (COMMON DEVICE NAME- CORRECTED TO "INSULIN PUMP"). (PROCODE- CORRECTED TO "LZG"). PMA/510K #- ADDED "K111210."
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED AFTER BECOMING UNRESPONSIVE AND EXPERIENCING A LOW BLOOD GLUCOSE (BG) LEVEL; HOWEVER, NO SPECIFIC BG VALUE WAS PROVIDED. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER TO OBTAIN DETAILS SURROUNDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 791536 | INSULIN PUMP | LZG | TANDEM DIABETES CARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Hospitalization| L |