FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMPACT TEST DRUM
MDR report key: 1122856
·
Received August 14, 2008
Report
- Report Number
- 1823260-2008-06220
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- August 9, 2008
- Report Date
- August 14, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K031755
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
CUSTOMER'S HUSBAND REPORTED BLOOD GLUCOSE RESULTS OF 330 MG/DL, 140 MG/DL AND 140 MG/DL WITHIN 10 MINS ON THE COMPACT PLUS SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, REPLACEMENT 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 | LFR | ROCHE DIAGNOSTICS | 20673943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | MOBIC 175MG/DAY 1 YR| BONIVA 150MG/MONTH - 2 YRS| COLACE 200MG/DAY - 2 MONTHS| SOTALOL 80MG/DAY - 1 YR| COUMADIN 3MG/DAY - 5 MONTHS| MAGNESIUM 64MG/DAY - 1 YR| NOVOLIN R 100 SLIDING SCALE - 2 MONTHS| HUMULIN 70/30 45 UNITS/DAY - 5 YRS| SANCTURA XR 160MG/DAY 2 MONTHS| LABETALOL 400MG/DAY - 1 YR| LINSINOPRIL 40MG/DAY - 1 YR| CLONIDINE 0.4MG/DAY - 1 YR| LASIX 42MG/DAY - 1 YR| PROTONIX 140MG/DAY - 2 MONTHS| TRAZODONE 50MG/DAY - 1 MONTH| FERROUS SULPHATE 325MG/DAY 2 MONTHS |