FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK PLUS
MDR report key: 2012988
·
Received March 4, 2011
Report
- Report Number
- 2183996-2011-00427
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- January 1, 2011
- Report Date
- February 18, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- FRN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS 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.
Description of Event or Problem · 1
THE PATIENT REPORTED ON ONE OCCASION ((B)(6) 2011) THE INFUSION SET LEAKED AT THE HEADSET CONNECTION TO THE TUBING. ON SEVERAL OCCASIONS ((B)(6) 2011) THE INFUSION SET BECAME DISCONNECTED AT THE HEADSET CONNECTION. THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE OF UP TO 300 MG/DL AS A RESULT. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS REQUESTED TO 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 | 42 YR | INSULIN| INSULIN INFUSION PUMP |