FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMPACT TEST DRUM
MDR report key: 1880231
·
Received October 22, 2010
Report
- Report Number
- 1823260-2010-06333
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- October 14, 2010
- Report Date
- December 13, 2010
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 3.2 MMOL/L, 7.8 MMOL/L, AND 16 MMOL/L. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DUE TO PATIENT PHYSIOLOGY THERE WAS EXTRACARDIAC STIMULATION. THE LEAD WAS REPROGRAMMED AND IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® COMPACT TEST DRUM | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | 20723845 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 080 YR | NOVOMIX INSULIN| "PANTALOC" |