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 NEG BREAKPOINT COMBO 47 B1017-417 manufactured by Siemens Healthcare Diagnostics Inc..
[4230748]
A customer complaint was received for qc holding for 42 hours when previously results were available earlier. Results were not duplicated by siemens. It is unknown if treatment was delayed or withheld. There are no reports of adverse health consequences associated with the discrepant results. Siemens conducted a field correction, internal number (b)(4) on (b)(4), 201, for out-of-range quality control results for qc p. Aeruginosa atcc 27853 vs. Arg or false negative arg results with clinical isolates if the panels pass qc testing. In addition, 42 hour identification panel hold may occur due to a weak arg reaction on the neg breakpoint combo 47, b1017-417 panels, lot number 2013-11-13. The customer letter stated any remaining inventory should be discarded. A review of complaints associated with this field correction determined a mdr was required.
Patient Sequence No: 1, Text Type: D, B5
[11605151]
Method: actual device not evaluated - retention samples tested. Results: no results available since not evaluation performed. Retention samples tested. Conclusion: device not returned - retention samples testing did not duplicate the results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2014-00011 |
| MDR Report Key | 3704684 |
| Report Source | 05 |
| Date Received | 2014-01-17 |
| Date of Report | 2013-01-22 |
| Date of Event | 2013-01-22 |
| Date Mfgr Received | 2013-01-22 |
| Device Manufacturer Date | 2012-11-01 |
| 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 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEG BREAKPOINT COMBO 47 |
| Generic Name | NEG BREAKPOINT COMBO 47 |
| Product Code | LTT |
| Date Received | 2014-01-17 |
| Model Number | NA |
| Catalog Number | B1017-417 |
| Lot Number | 11/13/2013 |
| ID Number | NA |
| Device Expiration Date | 2013-11-13 |
| 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 |