MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-09-25 for LABPRO COMPUTER manufactured by Siemens Healthcare Diagnostics, Inc..
[4946814]
It was reported that the panel processing customization window in (b)(4) allows the operator to leave unchecked autoscan-4 (as4) for 24 hours holds for enterococci and vancomycin (dried overnight). When unchecked, the 24 hour hold becomes recommended rather than required for vancomycin (va) mic result. If this occurs, it would be possible to report a potentially false susceptible interpretation for enterococci and va because the panel was not held to 24 hours.
Patient Sequence No: 1, Text Type: D, B5
[12172472]
(b)(4). Method: testing was not performed on the device evaluation. Results: no results available since no evaluation performed. Conclusions: conclusion not yet available evaluation in progress. (b)(4) is a custom-designed software version designed to work only with an autoscan-4 instrument and automated inoculation and incubation system. Only one customer in (b)(6)is using this (b)(4) version v3. 5. The software is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
[30230531]
This is an internal complaint. Further investigation revealed a gap in the procedural requirements for assay and software design controls. The procedure did not make provisions to document software considerations, in addition to the algorithm. The procedure was revised to include this requirement, as well as other requirements for additional applicable detailed labeling information. For example, instructions were added for the labpro operator's guide in order to document requirements that affect the software. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2014-00039 |
| MDR Report Key | 4134669 |
| Report Source | 07 |
| Date Received | 2014-09-25 |
| Date of Report | 2014-09-05 |
| Date of Event | 2014-09-05 |
| Date Mfgr Received | 2015-05-22 |
| Date Added to Maude | 2014-10-07 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NORMA RAHILL |
| Manufacturer Street | 2040 ENTERPRISE BLVD. |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163713031 |
| Manufacturer G1 | BECKMAN COULTER |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LABPRO COMPUTER |
| Generic Name | LABPRO COMPUTER |
| Product Code | LRG |
| Date Received | 2014-09-25 |
| Operator | OTHER |
| 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 | WEST SACRAMENTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-25 |