MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-09-29 for MICROSCAN PROMPT INOCULATION SYSTEM-D B1026-10D manufactured by Dade Behring, Inc..
[654466]
Account reported to dade behring that they have observed insufficient growth (no results) on microscan dried overnight gram-positive and gram-negative panel type. Report was associated with only the identified prompt lot. No report of injury or illness associated with this issue.
Patient Sequence No: 1, Text Type: D, B5
[7977210]
Evaluation: performance testing of customer returns and retention samples. Results: in-house testing performed and confirmed insufficient growth issue with customer provided samples and also with retention samples. Conclusion: dade behring has initiated a field correction for this issue and notified customer of the potential for discrepant mic and/or identification results with clinical and qc isolates with the identified prompt inoculation system-d lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2006-00032 |
| MDR Report Key | 868114 |
| Report Source | 05 |
| Date Received | 2006-09-29 |
| Date of Report | 2006-09-20 |
| Date of Event | 2006-09-20 |
| Date Mfgr Received | 2006-09-20 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2007-06-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOSE UNTALAN |
| Manufacturer Street | 2040 ENTERPRISE BLVD. |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163743285 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | FCA 000264 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROSCAN PROMPT INOCULATION SYSTEM-D |
| Generic Name | PANEL INOCULATING SUPPLIES |
| Product Code | JSD |
| Date Received | 2006-09-29 |
| Model Number | NA |
| Catalog Number | B1026-10D |
| Lot Number | 20071127 |
| ID Number | NA |
| Device Expiration Date | 2007-11-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 849649 |
| Manufacturer | DADE BEHRING, INC. |
| Manufacturer Address | 2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-29 |