MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-10-09 for MICROSCAN PROMPT INOCULATION SYSTEM-D B1026-10D manufactured by Dade Behring, Inc..
[615113]
Account reported to dade behring that they had observed some skipped wells with qc and clinical isolates. Report was associated with only the identified prompt lot. Account verified the skipped wells manually and reported resistant results for those antimicrobials that had skipped wells. No report of injury or illness associated with this issue.
Patient Sequence No: 1, Text Type: D, B5
[7972300]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2006-00036 |
| MDR Report Key | 854697 |
| Report Source | 05 |
| Date Received | 2006-10-09 |
| Date of Report | 2006-09-28 |
| Date of Event | 2006-09-28 |
| Date Mfgr Received | 2006-09-28 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2007-05-24 |
| 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 | 2006-10-09 |
| 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 | 840281 |
| Manufacturer | DADE BEHRING, INC. |
| Manufacturer Address | 2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-09 |