MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-29 for ADVIA 1800 073-A021-01 manufactured by Siemens Healthcare Diagnostics Inc..
[3455589]
A discordant, falsely elevated hemoglobin a1c (hba1c) result was obtained on one patient sample on an advia 1800 instrument. Two samples were obtained from the patient; one sample was tested on an advia 1800 and the other sample was tested on an alternate system. A higher result was obtained on the advia 1800 instrument. Both results were reported to the physician(s), who questioned the difference in the results. It is unknown if the sample was rerun. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated hba1c result.
Patient Sequence No: 1, Text Type: D, B5
[10710405]
A siemens technical applications specialist (tas) visited the customer site. The customer and the tas performed two hba1c comparison studies between the advia 1800 instrument and the alternate instrument. The difference between the mean of the patient samples on the advia 1800 and the mean of the patient samples on the alternate instrument were within the expected ranges stated in the advia chemistry instructions for use for hba1c. The cause of the discordant, falsely elevated hba1c result on one patient sample was unknown. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2013-00194 |
| MDR Report Key | 3131853 |
| Report Source | 05,06 |
| Date Received | 2013-05-29 |
| Date of Report | 2013-05-02 |
| Date of Event | 2013-04-18 |
| Date Mfgr Received | 2013-05-02 |
| Date Added to Maude | 2013-08-08 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | PDJ |
| Date Received | 2013-05-29 |
| Model Number | ADVIA 1800 |
| Catalog Number | 073-A021-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-29 |