FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK PLUS
MDR report key: 2073003
·
Received April 21, 2011
Report
- Report Number
- 2183996-2011-01144
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 25, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- FRN
- PMA / PMN Number
- K100704
- Removal / Correction Number
- Z-1490-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WILL BE RETURNED FOR EVAL.
Description of Event or Problem · 1
ON (B)(6) 2011, THE PT REPORTED HE BEGAN TO FEEL ILL IN (B)(6) 2011 WHILE AT THE DOCTOR'S OFFICE FOR A CT SCAN AND HE FOUND THE INFUSION SET CANNULA HAD EXITED HIS BODY AND WAS BENT NEAR THE ADHESIVE. HIS BLOOD GLUCOSE MEASURED 400 MG/DL WHEN HE ARRIVED HOME. HIS NORMAL BLOOD GLUCOSE LEVEL IS 100 MG/DL. HE CHANGED THE INFUSION SET AND BOLUSED THROUGH HIS INFUSION DEVICE TO LOWER HIS BLOOD GLUCOSE. HE USED THE INSERTION DEVICE TO INSERT THE HEADSET AND HE REPORTED NO ISSUES WITH INSERTION OR REMOVAL. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE ALLEGED PRODUCT WAS DISCARDED. NO PRODUCT WILL BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK FLEXLINK PLUS | INSULIN INFUSION SET | FRN | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | GWX184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | INSULIN INFUSION PUMP| INSULIN |