FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® PERFORMA TEST STRIPS
MDR report key: 1993162
·
Received February 16, 2011
Report
- Report Number
- 1823260-2011-00862
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- October 13, 2010
- Report Date
- April 8, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE PERFORMA SYSTEM WITHIN 10 MINUTES: 6.2 MMOL/L, 4.1 MMOL/L, 3.2 MMOL/L, 2.9 MMOL/L, AND 3.3 MMOL/L. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. CUSTOMER SELF TREATED WITH A BANANA AND A GLASS OF JUICE. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.
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 | 321067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 050 YR |