FDA Adverse Event
Summary report: N
ROCHE
MDR report key: 476329
·
Received July 21, 2003
Report
- Report Number
- MW4003553
- Date Received
- July 21, 2003
- Report Date
- May 16, 2003
- Manufacturer
- ROCHE DIAGNOSTICS CORP.
- Product Code
- CFR
- Report Source
- Voluntary report
- Reporter Location
- VA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
PHARMACIST ORDERED GLUCOSE TEST STRIPS AND SOLD A BOX TO A CUSTOMER WHO HAD DIFFICULTY USING THE TEST STRIPS ON THEIR INTENDED GLUCOSE METER. THE PT TELEPHONED THE MANUFACTURER, WHO INDICATED TAHT THE STRIPS COULD NOT BE USED WITH PT'S METER, EVEN THOUGH PRODUCT IS INTENDED FOR THAT METER. THE PHARMACIST NOTICED THE PRODUCT BOXES ARE LABELED IN SEVERAL LANGUAGES AND APPEAR TO BE PACKED FOR THE EUROPEAN MARKET. THE BOXES WERE CA. 10$ CHEAPER THAN ROCHE STRIPS PREVIOUSLY PURCHASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROCHE | TEST STRIPS, GLUCOSE | CFR | ROCHE DIAGNOSTICS CORP. | * | 446 | |
| 2 | ROCHE | TEST STRIPS, GLUCOSE | CFR | ROCHE DIAGNOSTICS CORP. | * | 447 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |