MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-17 for MICROFAST 5J J1016-83 manufactured by Siemens Healthcare Diagnostics Inc..
[18363114]
A customer complaint was received for s. Agalactiae isolate with susceptible results for clarithromycin and levofloxacin using a walkaway but visually were resistant. Results could not be confirmed as the isolate was not sent to siemens by the customer. Panels were visual verified and correct results were reported to the physician. There was no adverse impact to pt treatment. Siemens conducted a field correction, internal number (b)(4), fda number z-1272-2013 on march 6, 2013, for false skipped wells and false susceptible misreads with s. Agalactiae affecting multiple antimicrobial agents on microscan microstrep plus type 5 panels ((b)(4)), microfast type 5j panels ((b)(4)) and microfast type 7j panels ((b)(4)). The customer letter stated results should be visually verified for s. Agalactiae isolates on the above panel types. A review of complaints associated with this field correction determined a mdr was needed.
Patient Sequence No: 1, Text Type: D, B5
[18666918]
Evaluation: method (3367) use testing. Results: definition - discrepant results between visual and instrument interpretations. Conclusion: design deficiency - discrepant results between visual and instrument interpretations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2014-00008 |
| MDR Report Key | 3704686 |
| Report Source | 05 |
| Date Received | 2014-01-17 |
| Date of Report | 2013-01-21 |
| Date of Event | 2013-01-16 |
| Date Mfgr Received | 2013-01-21 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2014-05-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LESLIE ARDIZONE |
| Manufacturer Street | 2040 ENTERPRISE BLVD. |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163743075 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1272-2013 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROFAST 5J |
| Generic Name | MICROFAST 5J |
| Product Code | LTT |
| Date Received | 2014-01-17 |
| Model Number | NA |
| Catalog Number | J1016-83 |
| Lot Number | 2013-10-29 |
| ID Number | NA |
| Device Expiration Date | 2013-10-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-17 |