FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK
MDR report key: 2081694
·
Received April 13, 2011
Report
- Report Number
- 2183996-2011-01013
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 15, 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
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE PATIENT'S MOTHER REPORTED THE PATIENT'S INFUSION SET TUBING BROKE AWAY AT THE LUER LOCK AND THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE OF 18-26 MMOL/L (324-468 MG/DL) AND KETONES OF 1.8-2.6. 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 | INSULIN INFUSION SET | FRN | ROCHE INSULIN DELIVERY SYSTEMS, INC. | NA | 7490202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN| INSULIN INFUSION PUMP |