FDA Adverse Event
Injury
Summary report: N
B-D
MDR report key: 476229
·
Received July 21, 2003
Report
- Report Number
- MW4003543
- Event Type
- Injury
- Date Received
- July 21, 2003
- Report Date
- May 20, 2003
- Manufacturer
- B-D
- Product Code
- JHI
- Report Source
- Voluntary report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DR. STATED THAT PTS HAVE BEEN USING THE REFERENCED DEVICES WITH FEW FALSE POSITIVES DURING THE 13 YEARS HE HAS BEEN IN PRACTICE. HOWEVER, IN THE LAST 6 MONTHS, HE HAS NOTICED A SHARP INCREASE IN THE NUMBER OF FALSE POSITIVES. DR. STATED THAT HE CALLED ONE MFR FOR ONE OF THE DEVICES THAT APPEARED TO BE PROBLEMATIC AND WAS TOLD THAT THERE WAS NO QUALITY ISSUE. HOWEVER, IT WAS EXPLAINED TO HIM THAT THE DEVICE IS MFR'ED USING MOUSE MONO-CLONAL CELLS WHICH CAN PRODUCE A FALSE POSITIVE IF THE INDIVIDUAL BEING TESTED HAS BEEN EXPOSED TO OR HANDLED MICE. THE TWO DEVICES THAT DR. HAS NOTICED THE MOST PROBLEM WITH ARE OV-CON 25 MFR'ED BY "BECTION-DICTON" AND QUIDEL MFR'ED BU QUICKVIEW, SAN DIEGO, CA. DR. IS SENDING ADDITION INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | B-D | OV-CON 25 | JHI | B-D | * | * | |
| 2 | QUICKVIEW | QUIDEL PREGNANCY TEST | JHI | QUIDEL | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |