FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK PLUS
MDR report key: 2081678
·
Received April 13, 2011
Report
- Report Number
- 2183996-2011-00994
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 16, 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
- NJ, 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, THE PATIENT REPORTED EXPERIENCING INSULIN LEAKAGE WHILE USING THE INFUSION SETS. SHE STATED SHE SMELLED INSULIN AND NOTICED MOISTURE AT THE HEADSET AFTER BOLUSING. HER BLOOD GLUCOSE ELEVATED TO 300 MG/DL. HER NORMAL BLOOD GLUCOSE LEVEL IS UNDER 200 MG/DL. WHEN SHE REMOVED THE HEADSET, SHE FOUND THE CANNULA WAS BENT. THIS OCCURRED WITHIN 12 HOURS OF INSERTING THE HEADSET. SHE BOLUSED TO LOWER HER READINGS. SHE STATED SHE MANUALLY INSERTS THE HEADSETS. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.
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 | 37 YR | INSULIN| INSULIN INFUSION PUMP |