MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-01 for MICROSTREP PLUS TYPE 1 PANELS B1027-201 manufactured by Siemens Healthcare Diagnostics Inc..
[19723682]
A customer complaint was received for s. Agalactiae isolate with susceptible results for erythromycin using a walkaway but visually the results were resistant. Panels were visually verified and the correct "resistant" results were reported to the physician. There was no adverse impact to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[19860652]
Siemens had conducted a field correction, (b)(4), for false skipped wells and false susceptible misreads with s. Agalactiae affecting multiple antimicrobial agents on microscan microstrep plus type 1 panels (b1027-201), microstrep plus type 5 panels (b1016-905), microfast type 5j panels (j1016-83) and microfast type 7j panels (j1016-84). The customer letter stated results should be visually verified for s. Agalactiae isolates on the above panel types. Additionally all subsequent lots were manufactured with updated info on this limitation. Siemens confirmed that this customer received the initial customer notification associated with fda recall (b)(4) and that the lot was manufactured with the updated info (confirmed through a review of the manufacturing records).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2014-00016 |
| MDR Report Key | 3888424 |
| Report Source | 05 |
| Date Received | 2014-04-01 |
| Date of Report | 2014-03-07 |
| Date of Event | 2014-03-07 |
| Date Mfgr Received | 2014-03-07 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-07-08 |
| 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 | 0 |
| 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 | 9163743031 |
| 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 TYPE 1 PANELS |
| Generic Name | MICROSTREP PLUS TYPE 1 |
| Product Code | LTT |
| Date Received | 2014-04-01 |
| Catalog Number | B1027-201 |
| Lot Number | 2014-08-05 |
| Device Expiration Date | 2014-08-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-04-01 |