FDA Adverse Event
Injury
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1822844
·
Received August 30, 2010
Report
- Report Number
- 2531779-2010-01131
- Event Type
- Injury
- Date Received
- August 30, 2010
- Date of Event
- July 28, 2010
- Report Date
- July 28, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PT REPORTED THAT HER BLOOD GLUCOSE WAS 303 MG/DL WHEN SHE WOKE UP ON (B)(6)2010 AND HAD NOT DELIVERED ANY BOLUSES AT THE TIME OF THE CALL TO CUSTOMER SUPPORT (2:48 PM) WHEN HER BLOOD GLUCOSE WAS 512 MG/DL. PT AND HUSBAND DENIED SIGNS OR SYMPTOMS OF DKA; THE PT DID NOT REQUIRE MEDICAL INTERVENTION TO TREAT THE HYPERGLYCEMIA. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT EXPERIENCED HYPERGLYCEMIA (512 MG/DL) AND IT WAS RESOLVED WITHOUT MEDICAL INTERVENTION WITHIN 24 HOURS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ONE TOUCH PING | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |