MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-11-13 for POS COMBO 21 B1017-201 manufactured by Siemens Healthcare Diagnostics, Inc..
[5109719]
It was reported that the customer ran an api survey isolate from an urine sample and recovered an identification of e. Faecalis using pos combo 21 panel (lot 2014-08-27) on (b)(6)2014. Multiple antimicrobics gave false susceptible/lowered minimal inhibitory concentration ( mic). The customer repeated the testing on (b)(6) 2014 for the same isolate using pc21 panel (lot 2015-04-15) and again recovered an identification of e. Faecalis with multiple antimicrobics gave false susceptible/lowered minimal inhibitory concentration (mic). There was no patient involved as this was a proficiency survey isolate.
Patient Sequence No: 1, Text Type: D, B5
[12550586]
Conclusion: a device problem related to the user not following the manufacturer's instructions. Device not returned. The manufacturer followed up with the customers and further investigation suggested that the customer power the instrument off in the evening. When turning it back on the customer allowed between 30 to 60 minutes for the system to warm up. The customer was reminded to follow the operators manual to warm up the instrument up to 60 minutes. On (b)(6) 2014, the customer repeated the test using pc 21 panel (lot 2015-04-15) and the system the interpretation results matched with the api expected results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2014-00042 |
| MDR Report Key | 4254370 |
| Report Source | 99 |
| Date Received | 2014-11-13 |
| Date of Report | 2014-10-14 |
| Date of Event | 2014-07-02 |
| Date Mfgr Received | 2014-10-14 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2014-11-25 |
| 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 | JOSE UNTALAN |
| Manufacturer Street | 2040 ENTERPRISE BLVD. |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163743031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POS COMBO 21 |
| Generic Name | POS COMBO 21 |
| Product Code | LRG |
| Date Received | 2014-11-13 |
| Model Number | B1017-201 |
| Catalog Number | B1017-201 |
| Lot Number | 2015-04-15 |
| Device Expiration Date | 2015-04-15 |
| 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 | WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-13 |