MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-08-13 for POS COMBO 6.1J J1016-601J manufactured by Siemens Healthcare Diagnostics Inc..
[1152625]
Customer reported (b)(6) discrepancy. The hospital obtained (b)(6) results on the pos combo 6. 1j panel and (b)(6) results when tested against another test method also performed for the clinical isolate. Results were not reported to the physician. Treatment was not delayed or withheld. There are no reports of adverse health consequences associated with the discrepant result.
Patient Sequence No: 1, Text Type: D, B5
[8412772]
Routine monitoring of complaint history and performance trends to ensure performance is within claims. Results: based on a comparison to another test method, an incorrect interpretation was provided for this isolate. Conclusions: there are no reports of adverse health consequences associated with the discrepant result. Product is within performance claims. The cause of the (b)(6) results is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2009-00008 |
| MDR Report Key | 1474100 |
| Report Source | 05 |
| Date Received | 2009-08-13 |
| Date of Report | 2009-07-17 |
| Date of Event | 2009-07-17 |
| Date Mfgr Received | 2009-07-17 |
| Date Added to Maude | 2010-07-07 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POS COMBO 6.1J |
| Generic Name | DRIED GRAM POS PANEL |
| Product Code | LTT |
| Date Received | 2009-08-13 |
| Model Number | NA |
| Catalog Number | J1016-601J |
| Lot Number | NOT AVAILABLE |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| 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 | 2009-08-13 |