FDA Adverse Event
Malfunction
Summary report: N
MICROSCAN PROMPT INOCULATION SYSTEM-D
MDR report key: 854682
·
Received October 9, 2006
Report
- Report Number
- 2919016-2006-00038
- Event Type
- Malfunction
- Date Received
- October 9, 2006
- Date of Event
- September 28, 2006
- Report Date
- September 28, 2006
- Manufacturer
- DADE BEHRING, INC.
- Product Code
- JSD
- Removal / Correction Number
- FCA 000264
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PERFORMANCE TESTING OF CUSTOMER RETURNS AND RETENTION SAMPLES. IN-HOUSE TESTING PERFORMED AND CONFIRMED INSUFFICIENT GROWTH ISSUE WITH CUSTOMER PROVIDED SAMPLES AND ALSO WITH RETENTION SAMPLES. DADE BEHRING HAS INITIATED A FIELD CORRECTION FOR THIS ISSUE AND NOTIFIED CUSTOMERS OF THE POTENTIAL FOR DISCREPANT MIC AND/OR IDENTIFICATION RESULTS WITH CLINICAL AND QC ISOLATES WITH THE IDENTIFIED PROMPT INOCULATION SYSTEM-D LOT.
Description of Event or Problem · 1
ACCOUNT REPORTED TO DADE BEHRING THAT THEY HAD INTERMITTENTLY OBSERVED INSUFFICIENT GROWTH (NO RESULTS) ON QC AND CLINICAL ISOLATES. ISSUE WAS ONLY ASSOCIATED WITH THE IDENTIFIED PROMPT LOT. ACCEPTABLE RESULTS WERE OBTAINED AFTER REPEATING THE TESTS. THERE WERE NO REPORTS 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 |