FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK PLUS
MDR report key: 2081687
·
Received April 13, 2011
Report
- Report Number
- 2183996-2011-00984
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 15, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS, INC.
- Product Code
- FRN
- PMA / PMN Number
- K100704
- Removal / Correction Number
- Z-1492-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WILL BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
ON (B)(6) 2011, PATIENT REPORTED TWO INFUSION SETS DID NOT INSERT PROPERLY, AND THIS RESULTED IN INSULIN LEAKAGE AND THE HEADSET FALLING OFF HIS BODY. THE INFUSION CANNULAS WERE ALSO BENT. BLOOD GLUCOSE ELEVATED ABOVE 400 MG/DL, AND PATIENT CHANGED HIS INFUSION HEADSET AND BOLUSED FOR TREATMENT. TARGET BLOOD GLUCOSE IS 100-150 MG/DL. INSERTION DEVICE WAS USED TO INSERT THE HEADSETS, AND THE ISSUES WERE NOTICED 2 HOURS FOLLOWING INSERTION. ALLEGED INFUSION SETS WERE NOT AVAILABLE TO RETURN FOR EVALUATION. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | INSULIN INFUSION DEVICE| INSULIN |