FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® PERFORMA TEST STRIPS
MDR report key: 4861574
·
Received June 23, 2015
Report
- Report Number
- 3011393376-2015-01320
- Event Type
- Malfunction
- Date Received
- June 23, 2015
- Date of Event
- May 27, 2015
- Report Date
- July 29, 2025
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.
Description of Event or Problem · 1
CALLER REPORTED PERFORMA SYSTEM BLOOD GLUCOSE RESULTS OF 324 MG/DL AND 112 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406073 | ACCU-CHEK ® PERFORMA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIABETES CARE, INC. | NA | 473298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female |