FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 2151642
·
Received June 28, 2011
Report
- Report Number
- 2183996-2011-01953
- Event Type
- Injury
- Date Received
- June 28, 2011
- Date of Event
- June 19, 2011
- Report Date
- June 21, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- LZG
- PMA / PMN Number
- K060876
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WILL BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
ON (B)(6) 2011, COMPANY REPRESENTATIVE REPORTED HE RECEIVED A CALL FROM THE PATIENT'S DE STATING HE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011 FOR DKA. COMPANY REPRESENTATIVE STATED HE DOES NOT HAVE ANY INFORMATION SURROUNDING THE INCIDENT. ON CALL BACK ON (B)(6) 2011, COMPANY REPRESENTATIVE REPORTED HE SPOKE WITH THE PATIENT AND THE PATIENT STATED THERE ARE NO ISSUES WITH HIS INFUSION DEVICE AT THIS TIME. COMPANY REPRESENTATIVE STATED THE PATIENT REPORTED HIS INFUSION DEVICE IS WORKING AS INTENDED. ATTEMPTS TO FOLLOW UP WITH THE PATIENT WERE UNSUCCESSFUL. NO PRODUCT RETURN WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT | INSULIN INFUSION PUMP | LZG | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O| R | INSULIN INFUSION SET| INSULIN |