MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-09-11 for SYNERGIES PLUS NEGATIVE URINE COMBO 2 B1025-112 manufactured by Siemens Healthcare Diagnostics, Inc..
[19294320]
A customer complaint was received for k. Pneumoniae isolate that was false susceptible imipenem on synergies plus negative urine type 2 panels when read by the walkaway but visually the results were resistant (growth in the wells). The customer isolate was tested at microscan and the false susceptible were duplicated. It is unknown if the false susceptible results were reported to the physician or if therapy was delayed or withheld. Siemens microscan conducted a field correction, internal number (b)(4) (fda number has not been assigned) on 08/21/2013 for false susceptible imipenem and meropenem with synergies plus negative panels. The customer letter stated that due to false susceptible results with imipenem and meropenem results should not be reported for susceptible or intermediate imipenem or meropenem on microscan synergies plus gram negative panels. As part of the field action, complaints were reviewed and it was determined a mdr was needed for this customer complaint.
Patient Sequence No: 1, Text Type: D, B5
[19471634]
Method - customer isolate was tested at microscan using a synergies plus negative panel. Results - discrepant results were confirmed. Conclusions - microscan instrument and visual reads did not provide the same results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2013-00011 |
| MDR Report Key | 3368332 |
| Report Source | 05 |
| Date Received | 2013-09-11 |
| Date of Report | 2013-06-11 |
| Date of Event | 2013-05-31 |
| Date Mfgr Received | 2012-06-11 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2013-12-17 |
| 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 | MSSW 13-02 (FDA NUMBER |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGIES PLUS NEGATIVE URINE COMBO 2 |
| Generic Name | SYNERGIES PLUS NEGATIVE BREAKPOINT COMB |
| Product Code | LTT |
| Date Received | 2013-09-11 |
| Catalog Number | B1025-112 |
| Lot Number | 2013-12-17 |
| ID Number | NA |
| Device Expiration Date | 2013-12-17 |
| 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 | 2013-09-11 |