FDA Adverse Event
Injury
Summary report: N
OT PING INSULIN PUMP
MDR report key: 2222628
·
Received August 25, 2011
Report
- Report Number
- 2531779-2011-02242
- Event Type
- Injury
- Date Received
- August 25, 2011
- Report Date
- March 2, 2011
- Manufacturer
- ANIMAS CORP
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
"REPORTER: (B)(6) FROM (B)(6). COMPLAINT: HOSPITALIZATION R/T HIGH BG. ANALYSIS: ANIMAS CANADA REP SPOKE TO PT'S WIFE AND FOUND PT WAS ADMITTED TO HOSPIRTAL ON (B)(6) FOR FLULIKE SYMPTOMS AND FOUND HIGH BG AND DKA. PT HAD N/V, ABD CRAMPS, SOB AND NOT SURE IF HAD CHEST PAIN. PER ANIMAS REP W IFE REFUSING TO TALK TO PS DUE TO SO MUCH GOING ON AT THIS TIME. PT MAY BE GOING HOME ON FRIDAY. WIFE ASK THAT PS CALL HER ON (B)(6) 201 TO OBTAIN INFORMATION, WHEN PT IS OUT OF THE HOSPITAL. CONCLUSION: UNABLE TO CONLCUDE TILL TROUBLE SHOOT PUMP".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 369170 | OT PING INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | ANIMAS CORP | ONETOUCH PING INSULIN PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |