FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 1133556
·
Received August 22, 2008
Report
- Report Number
- 1823260-2008-06372
- Event Type
- Malfunction
- Date Received
- August 22, 2008
- Date of Event
- August 6, 2008
- Report Date
- August 22, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER'S CARETAKER REPORTED BLOOD GLUCOSE RESULTS OF 110 MG/DL AND 56 MG/DL WITHIN 10 MINS ON THE COMPACT PLUS SYSTEM. CUSTOMER REPORTED SYMPTOMS OF HYPOGLYCEMIA, EMT'S WERE CALLED, TESTED CUSTOMER'S BLOOD GLUCOSE AT 58 MG/DL, TREATED/TRANSPORTED TO EMERGENCY ROOM. 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 COMFORT CURVE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS-LFR | LFR | ROCHE DIAGNOSTICS | 550635 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | HUMALOG SLIDING SCALE| "CHOLESTEROL PILL"| ZOLOFT| TENORMIN 100MG/DAY| ASPIRIN| REGLAN| AMARYL-| LASIX 80MG/DAY- "A LONG TIME"| LANTUS 17 UNITS/DAY |