FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® PERFORMA TEST STRIPS
MDR report key: 1882383
·
Received October 26, 2010
Report
- Report Number
- 1823260-2010-06355
- Event Type
- Malfunction
- Date Received
- October 26, 2010
- Date of Event
- August 14, 2010
- Report Date
- October 26, 2010
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). WILL NOT BE RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE PERFORMA COMBO SYSTEM WITHIN 10 MINUTES: HI (GREATER THEN 33.3 MMOL/L), 7.3 MMOL/L, 24.3 MMOL/L, AND HI. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CUSTOMER NO LONGER HAS THE TEST STRIPS.
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 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 023 YR | NOVORAPID| SPIRIT INSULIN PUMP |