FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH ULTRA
MDR report key: 728920
·
Received July 11, 2005
Report
- Report Number
- 2939301-2005-02902
- Event Type
- Malfunction
- Date Received
- July 11, 2005
- Report Date
- June 29, 2005
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM.
Description of Event or Problem · 1
BLOOD GLUCOSE RESULTS OF "158, 150, 253 AND 143 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF PRECISION. IN ADDITION TO THE PRECISION INACCURACY CONCERN, THE PATIENT/REPORTER ALSO MENTIONED THE STRIPS WERE DAMAGED. DAMAGED STRIPS CAN CAUSE INACCURATE TEST RESULTS ON THE METER. THERE WAS NO ALLEGATION OF HARM OR INJURY. THE STRIPS AND CONTROL SOLUTION HAVE BEEN REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH ULTRA | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN, INC. | NA | 2536657 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |