MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-09-27 for MICROSCAN PROMPT INOCULATION SYSTEM-D B1026-10D manufactured by Dade Behring, Inc..
[20824845]
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.
Patient Sequence No: 1, Text Type: N, H10
[20835697]
Single account reported to dade behring that they observed insufficient growth with quality control organisms m. Luteus and s. Bovis. No growth was seen in growth well on microscan panels. Account also experiencing multiple skipped wells. Multiple panels (both gram-positive and gram-negative) are showing issue with identified prompt inoculation system-d lot but not when set up with other inoculum method. Visual results and instrument results are in agreement. No pt associated with the malfunction, results were obtained with qc organisms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919016-2006-00016 |
| MDR Report Key | 866310 |
| Report Source | 05 |
| Date Received | 2006-09-27 |
| Date of Report | 2006-09-27 |
| Date of Event | 2006-08-29 |
| Date Mfgr Received | 2006-08-29 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2007-06-19 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROSCAN PROMPT INOCULATION SYSTEM-D |
| Generic Name | PANEL INOCULATING SUPPLIES |
| Product Code | JSD |
| Date Received | 2006-09-27 |
| 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 | 848274 |
| Manufacturer | DADE BEHRING, INC. |
| Manufacturer Address | 2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-27 |