MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-27 for EMIT 2000 DIGOXIN ASSAY 10445315 manufactured by Siemens Healthcare Diagnostics Inc..
[81401334]
A siemens healthcare diagnostics inc. (siemens) field service engineer (fse) was dispatched to the customer site to determine the cause of the internal quality control recovering out of range. From the achieve files, siemens calculated the average internal quality control for level 1 and 2 and determined that they were both below the target range: internal qc level 1 recovered at 0. 43 ng/ml and internal qc level 2 recovered at 1. 40 ng/ml. The fse performed a system fill, reagent probe accuracy and abs check. The abs test results recovered within specifications of %cv<1. 0. To troubleshoot the issue, the fse performed a 10 fold measurement with the digoxin calibrator and internal quality control level 1 measurement mean from the 10 fold measurement recovered below assay lower range (0. 3 ng/ml)and below the instruction for use (ifu) target range (0. 47 - 0. 71 ng/ml). Internal quality control level 2 measurement mean from the 10 fold measurement recovered below the ifu target range (1. 42 - 1. 92 ng/ml). As of july 21, 2017, the customer indicated that the quality controls are increasing and recovering well. The cause of the internal quality controls recovering out of range is unknown. The customer incorrectly ran patient samples when internal quality controls recovered out of range. Based on the emit 2000 digoxin assay, "if any control result is not within the established control limits, despite repeat testing or recalibration, call for technical assistance. Once you have validated the calibration curve, run patient samples". Furthermore, the incorrect instrument setting for the assay range was shown on the analyser. Based on the customer's viva-e analyser folder files, the low concentration was set to 0. 2 ng/ml. Based on the application sheet "rev. Vdig. 7 2012-02-27 msw: 545q-us" and digoxin ifu, the assay range is 0. 3 - 5 ng/ml and the "low concentration" has to be set to 0. 3 ng/ml. " the testing of patient samples while qc is out of range is a user error. The instrument and reagents are performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[81401335]
Digoxin results were obtained for 2 patient samples when the internal quality controls (qc) recovered out of range on the viva-e analyser. These results were expected for these patient and not questioned by the physician(s). The qc range was 0. 47 - 0. 71 ng/ml for biorad liquicheck level 1 (lot 27711) and 1. 42 - 1. 92 ng/ml biorad liquicheck level 2 (lot 27712). On the day of the event, internal qc recovered 0. 43 ng/ml for level 1 and 1. 41 ng/ml for level 2. Upon duplication, the internal qc recovered 0. 52 ng/ml for level 1 and 1. 46 ng/ml for level 2. It is unknown if other patient samples were run while the internal qc recovered out of range. There are no known reports of patient intervention or adverse health consequences due to the customer running patient samples while internal qc recovered out of range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00610 |
| MDR Report Key | 6746852 |
| Date Received | 2017-07-27 |
| Date of Report | 2017-07-27 |
| Date of Event | 2017-06-27 |
| Date Mfgr Received | 2017-07-04 |
| Date Added to Maude | 2017-07-27 |
| 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 | ELIZABETH BERNASCONI |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242495 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EMIT 2000 DIGOXIN ASSAY |
| Generic Name | EMIT 2000 DIGOXIN ASSAY |
| Product Code | KXT |
| Date Received | 2017-07-27 |
| Model Number | EMIT 2000 DIGOXIN ASSAY |
| Catalog Number | 10445315 |
| Lot Number | J2 |
| Device Expiration Date | 2018-04-06 |
| 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 | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-27 |