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 POSITIVE COMBO 33 B1017-211 manufactured by Siemens Healthcare Diagnostics Inc..
[3746732]
Customer testing yielded (b)(6) discrepancies. The hospital obtained (b)(6) susceptible results on siemens pos combo 33 panels but customer's offline tests indicated a (b)(6). Based on the off-line results, the customer edited the (b)(6) results to "do not report" (nr) prior to reporting result. The results of a (b)(6) with the (b)(6) results suppressed (nr) were reported to the physician. Treatment was not delayed or withheld. There are no reports of adverse health consequences associated with the discrepant results.
Patient Sequence No: 1, Text Type: D, B5
[11115565]
Method - actual device not evaluated - the customer performed offline tests that are accepted as accurate. Results - the customer performed penicillin protein binding test and (b)(4) spectra (chromogenic) plate which were positive for (b)(6). Conclusion - no evaluation will be performed. The penicillin protein binding test and (b)(4) spectra (chromogenic) plate tests are routinely performed by laboratories and are believable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2013-00007 |
| MDR Report Key | 3368303 |
| Report Source | 05 |
| Date Received | 2013-09-11 |
| Date of Report | 2013-08-27 |
| Date of Event | 2013-08-25 |
| Date Mfgr Received | 2013-08-27 |
| Device Manufacturer Date | 2013-06-01 |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSITIVE COMBO 33 |
| Generic Name | POSITIVE COMBO 33 |
| Product Code | LTT |
| Date Received | 2013-09-11 |
| Model Number | NA |
| Catalog Number | B1017-211 |
| Lot Number | 2014-06-13 |
| ID Number | NA |
| Device Expiration Date | 2014-06-13 |
| 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 |