FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK PERFORMA TEST STRIPS
MDR report key: 2111731
·
Received June 2, 2011
Report
- Report Number
- 1823260-2011-02958
- Event Type
- Malfunction
- Date Received
- June 2, 2011
- Date of Event
- May 22, 2011
- Report Date
- September 29, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED RESULTS OF 354 MG/DL AND 129 MG/DL WITHIN 10 MINUTES ON THE PERFORMA NANO SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK PERFORMA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 470085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 061 YR |