MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-06-20 for GRAM NEGATIVE COMBO TYPE 44 PANEL B1017-401 manufactured by Siemens Healthcare Diagnostics Inc..
[3513864]
Customer and internal testing yields p. Aeruginosa isolate mic discrepancy with piperacillin/tazobactam compared to a reference lab. The hospital obtained p. Aeruginosa sensitive results for piperacillin/tazobactam on initial and repeat testing: initial test: neg combo 44, (b)(6) 2013. Repeat test: neg mic 38, lot 2014-03-21. Internal testing of the isolate with a reference method control yielded sensitive results but the reference lab results were resistant. The reference lab test method is unknown. The patient previously had piperacillin/tazobactam resistant results and was being treated. The mic discrepancy was reported to the physician but it is unknown if therapy was changed based on the results. The hospital laboratory states the patient had multiple issues that led to their death but it was unrelated to the piperacillin/tazobactam discrepancy.
Patient Sequence No: 1, Text Type: D, B5
[10756500]
Evaluations codes: method: actual device not evaluated - isolate tested on two microscan products and tested reference lab. Results: discrepant results compared to the reference lab results. Conclusions: no evaluation will be performed - additional testing performed by customer showed discrepant results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2013-00004 |
| MDR Report Key | 3186991 |
| Report Source | 00 |
| Date Received | 2013-06-20 |
| Date of Report | 2013-06-06 |
| Date of Event | 2013-05-20 |
| Date Mfgr Received | 2013-06-06 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2013-06-26 |
| 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 | GRAM NEGATIVE COMBO TYPE 44 PANEL |
| Generic Name | GRAM NEG COMBO 44 |
| Product Code | LTT |
| Date Received | 2013-06-20 |
| Model Number | NA |
| Catalog Number | B1017-401 |
| Lot Number | 2013-12-17 |
| ID Number | NA |
| Device Expiration Date | 2013-12-17 |
| 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 | 1. Death | 2013-06-20 |