MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-28 for POSITIVE COMBO 33 B1017-211 manufactured by Siemens Healthcare Diagnostics Inc.
[4759289]
It was reported that the customer performed the american proficiency institute (api) survey and the result identified as e. Faecium reported for vancomycin an mic =1 with susceptible interpretation. Customer ran specimen on a vanc agar screen plate and it showed growth. The customer repeated the same specimen on the next day and subsequent next day using turbidity with the same result; both initial and repeat results were visually confirmed. The expected answer for api survey was resistant to vancomycin. Customer reported that both qc diagnostic and pan l qc were passing. The customer also reported that they received the api results indicating that out of 180 results, 5 were reported susceptible vancomycin for this specimen. There was no report of pt injury or delay in treatment.
Patient Sequence No: 1, Text Type: D, B5
[12199993]
(b)(4). Method code: one isolate was submitted by the customer for eval. The isolate was tested in duplicate for mfr's technical support laboratory on positive combo type 34 panels using the turbidity standard and the prompt inoculation method. The panels were read on a walkaway-96 instrument at 24 hours. Result code: vancomycin vs e faecium was susceptible to the microscan dried panels. The results also matched for vancomycin susceptibility on the frozen reference panels and with disk diffusion validating that there was nothing wrong with the microscan panels. The discrepancy in the american proficiency institute (api) survey is likely due to vancomycin resistance mechanism having been lost as a result of repeated subcultures of the isolate. There was no report of pt injury or delay in treatment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2014-00033 |
| MDR Report Key | 4102750 |
| Report Source | 05 |
| Date Received | 2014-08-28 |
| Date of Report | 2014-08-08 |
| Date of Event | 2014-07-01 |
| Date Mfgr Received | 2014-08-08 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2014-09-25 |
| 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 | 9143743031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSITIVE COMBO 33 |
| Generic Name | GRAM POSITIVE PANEL TYPE 33 |
| Product Code | LRG |
| Date Received | 2014-08-28 |
| Model Number | B1017-211 |
| Catalog Number | B1017-211 |
| Lot Number | 2015-05-05 |
| Device Expiration Date | 2015-05-05 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-28 |