FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMPACT TEST DRUM
MDR report key: 1336609
·
Received March 10, 2009
Report
- Report Number
- 1823260-2007-05082
- Event Type
- Malfunction
- Date Received
- March 10, 2009
- Date of Event
- June 1, 2006
- Report Date
- June 11, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K031755
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL MEDICAL DATES:SYNTHROID - 0.015MG ONCE DAILY; NIFEDICAL XL - 30MG ONCE DAILY; TERAZOSIN - 10MG ONCE DAILY; SIMVASTATIN - 80MG ONCE DAILY; CTZ - 25MG ONCE DAILY; ASACOL - 400MG 2 TABS 3 TIMES DAILY; TRILEPTAL - 300MG TWICE DAILY; WARFARIN - 5MG ONCE DAILY.
Description of Event or Problem · 1
REPORTER ALLEGED DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF HI, BACK TO BACK WITH A RESULT OF 101 MG/DL WHEN TESTING PERFORMED 5 MINUTES APART ON THE COMPACT SYSTEM. NO ACTIONS WERE TAKEN OR TREATMENT REPORTEDLY RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.
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 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | NPH INSULIN 5UN & 6UN EACH DOSE ONCE DAILY| LANTUS 6UN ONCE DAILY| APIDRA 3UN TWICE DAILY |