FDA Adverse Event
Malfunction
Summary report: N
MICROSCAN PROMPT INOCULATION SYSTEM-D
MDR report key: 854624
·
Received October 9, 2006
Report
- Report Number
- 2919016-2006-00037
- 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
- GA, 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 OBSERVED SOME INSUFFICIENT GROWTH (NO RESULTS) THAT CLEARED UPON RETEST. REPORT WAS ASSOCIATED WITH ONLY THE IDENTIFIED PROMPT LOT AND ERRONEOUS REPORTS WERE NOT SENT OUT TO THE PHYSICIAN. 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 |