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 MICROSTREP PLUS 1 B1027-201 manufactured by Siemens Healthcare Diagnostics Inc..
[4339253]
Internal study observed misreads for 10 s. Agalactiae isolates with multiple antibiotics. Instrument and visual readings were discrepant. Siemens conducted a field correction, internal number (b)(4), fda number (b)(6) on (b)(4), 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
[11591872]
Method: use testing: isolated were tested at microscan using microstrep plus 1 panel. Results: incorrect data. Definition - discrepant results were confirmed. Conclusion: design deficiency - the microscan testing confirmed misreads.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2014-00009 |
| MDR Report Key | 3704685 |
| Report Source | 05 |
| Date Received | 2014-01-17 |
| Date of Report | 2012-07-20 |
| Date of Event | 2012-07-20 |
| Date Mfgr Received | 2013-07-20 |
| Device Manufacturer Date | 2012-05-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 | MICROSTREP PLUS 1 |
| Generic Name | MICROSTREP PLUS 1 |
| Product Code | LTT |
| Date Received | 2014-01-17 |
| Model Number | NA |
| Catalog Number | B1027-201 |
| Lot Number | 2013-05-21 |
| ID Number | NA |
| Device Expiration Date | 2013-05-21 |
| 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 |