MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-06-07 for CALCIUM_2 REAGENTS, CONCENTRATED (CA_2C) 10283344 manufactured by Siemens Healthcare Diagnostics Inc..
[110465072]
The customer informed siemens that they had used a new wedge for the ca_2c assay and the quality control samples resulted low out of range. Siemens technical application specialist (tas) indicated that the customer recalibrated the ca_2c assay on the same advia chemistry xpt instrument, and the quality control samples recovered within specifications. All patient samples that were falsely low during the initial run were repeated and the results obtained were acceptable to the customer. The cause for the falsely low ca_2c results is unknown. The device is performing within manufacturing specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[110465073]
Discordant falsely low results were obtained on four patient samples on an advia chemistry xpt system when using calcium_2 concentrated assay (ca_2c) reagent lot 424014. The 4 patient samples were repeated again on the same instrument and the results were acceptable. The initial falsely low results for the 4 patients were reported to the physician(s), and not questioned. The corrected repeat results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the falsely low results obtained for the ca_2 assay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00239 |
| MDR Report Key | 7579689 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-07 |
| Date of Report | 2018-06-27 |
| Date of Event | 2018-05-22 |
| Date Mfgr Received | 2018-06-20 |
| Date Added to Maude | 2018-06-07 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | RANDOX LABORATORIES LTD. |
| Manufacturer Street | 55 DIAMOND ROAD |
| Manufacturer City | CRUMLIN, CO. ANTRIM BT294QY |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BT29 4QY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CALCIUM_2 REAGENTS, CONCENTRATED (CA_2C) |
| Generic Name | CALCIUM_2 REAGENTS, CONCENTRATED (CA_2C) |
| Product Code | CJY |
| Date Received | 2018-06-07 |
| Model Number | CALCIUM_2 REAGENTS, CONCENTRATED (CA_2C) |
| Catalog Number | 10283344 |
| Lot Number | 424014 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-06-07 |