MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-10-21 for ADVIA 1800 073-A02-01 manufactured by Siemens Healthcare Diagnostics Inc..
[3883723]
Discordant, falsely elevated hemoglobin a1c (hba1c_3) results were obtained on three patient samples on an advia 1800 instrument. For the ratio component of the assay, total hemoglobin (thb), discordant results were flagged by the instrument. The hba1c_3 results were reported to the physician(s). The samples were re-spun and repeated on the same instrument, resulting as expected. The repeat results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low and falsely elevated hba1c_3 results.
Patient Sequence No: 1, Text Type: D, B5
[11159633]
An urgent medical device correction (umdc) 10814865 rev. A (for us customers) and urgent field safety notice (ufsn) 10814864 rev. A (for outside us customers), entitled "ratio parameters flagging behavior for all software versions" were sent to customers in (b)(4) 2013 to notify customers that the system will report results calculated using the ratio parameters feature without error flags when underlying individual test results used as part of the calculation are flagged. In cases where an error flag suppresses a numerical result, a ratio calculation will not be performed. If a numerical result is generated with a flag, the ratio will be reported without a flag. The ufsn requires customers to review and evaluate flags/marks associated with individual component assays before reporting ratio parameters assay results. Upon follow up with the customer, it was discovered that the customer is not spinning samples properly before sampling. It was also discovered, that the customer is reporting results that obtained a thb value of <7. According to the siemens advia chemistry hba1c instruction for use: "the thb_3 assay can be used for total hemoglobin concentrations from 7 to 24 g/dl". The cause of the customer reporting values with thb <7. 0 is failure to follow instructions. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2013-00499 |
| MDR Report Key | 3421741 |
| Report Source | 01,05,06 |
| Date Received | 2013-10-21 |
| Date of Report | 2013-09-26 |
| Date of Event | 2013-09-19 |
| Date Mfgr Received | 2013-09-26 |
| Date Added to Maude | 2014-01-23 |
| 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 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION NUMBER:3003637681 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO, 196-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-8558 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-09/09/2013-008-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | PDJ |
| Date Received | 2013-10-21 |
| Model Number | ADVIA 1800 |
| Catalog Number | 073-A02-01 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-21 |