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..
[3745366]
On initial testing ((b)(6) 2012), the customer observed a susceptible imipenem result on b1025-112 (lot number unavailable) survey d-12 k. Pneumoniae. The correct result for imipenem was intermediate or resistant. On repeat testing on (b)(6) 2012 using b1025-112, lot 2013-06-08, susceptible imipenem results were again observed for the walkaway read. When the panels were visually checked, there was growth in the imipenem wells (imipenem would be called resistant by manual read). Siemens microscan conducted a field correction, internal number mssw 13-02 (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 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
[11168305]
Method - customer results were compared to the survey expected results. Results - results received on the microscan product did not agree with survey results. Conclusion - results received on the microscan product did not agree with survey results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2013-00010 |
| MDR Report Key | 3368323 |
| Report Source | 05 |
| Date Received | 2013-09-11 |
| Date of Report | 2012-09-11 |
| Date of Event | 2012-05-27 |
| Date Mfgr Received | 2012-09-11 |
| Device Manufacturer Date | 2012-06-01 |
| 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 | 2013-06-08 |
| ID Number | NA |
| Device Expiration Date | 2013-06-08 |
| 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 |