FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT COMBO
MDR report key: 3192149
·
Received June 27, 2013
Report
- Report Number
- 2183996-2013-01177
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- June 19, 2013
- Report Date
- July 24, 2013
- Manufacturer
- ROCHE DIABETES CARE AG
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 1
THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. UP AND DOWN BUTTON MEETS THE SPECIFICATION.
Description of Event or Problem · 1
ON (B)(6) 2013, IT WAS REPORTED THAT THE UP AND DOWN BUTTONS ON THE PATIENT'S INFUSION DEVICE WERE NOT FUNCTIONING. THE PATIENT SWITCHED TO INSULIN INJECTIONS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291907 | ACCU-CHEK SPIRIT COMBO | INSULIN INFUSION DEVICE | LZG | ROCHE DIABETES CARE AG | 00700006863 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 079 YR |