FDA Adverse Event
Malfunction
Summary report: N
MICROSCAN PROMPT INOCULATION SYSTEM - D
MDR report key: 866304
·
Received September 27, 2006
Report
- Report Number
- 2919016-2006-00019
- Event Type
- Malfunction
- Date Received
- September 27, 2006
- Date of Event
- September 3, 2006
- Report Date
- September 27, 2006
- Manufacturer
- DADE BEHRING, INC.
- Product Code
- JSD
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: IN-HOUSE TESTING PERFORMED AND CONFIRMED INSUFFICIENT GROWTH ISSUE WITH CUSTOMER PROVIDED SAMPLES AND ALSO WITH RETENTION SAMPLES. CONCLUSION: INVESTIGATION HAS NOT BEEN COMPLETED.
Description of Event or Problem · 1
ACCOUNT REPORTED TO DADE BEHRING THAT INSUFFICIENT GROWTH (NO RESULTS) OCCURRED OVER PAST WEEK, ON GRAM POSITIVE OVERNIGHT PANELS WITH THE IDENTIFIED PROMPT LOT. ALTERNATE INOCULUM METHODS AND ALTERNATE PROMPT LOT WERE USED AND THE ACCOUNT HAD NO ISSUE WITH THEM. THERE WAS NO REPORT OF INJURY OR ILLNESS ASSOCIATED WITH THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROSCAN PROMPT INOCULATION SYSTEM - D | PANEL INOCULATING SUPPLIES | JSD | DADE BEHRING, INC. | NA | 20071127 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |