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 2018-04-27 for IMMULITE 2000 THYROGLOBULIN L2KTY manufactured by Siemens Healthcare Diagnostics Products, Limited.
[107077338]
A siemens customer service engineer (cse) was dispatched to the customer site. The instrument files for the immulite 2000 system were checked and the adjustment and quality control samples were reviewed. There were no problems identified with the instrument. The customer will continue to monitor the instrument. The system is performing within specifications. The cause of the discordant thyroglobulin result(s) is unknown. Siemens is investigating the issue. Mdr 2432235-2018-00187 is being filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[107077339]
Discordant results were obtained on a patient sample for the thyroglobulin (tg) assay on an immulite 2000 instrument when using kit lot 357. The sample was run neat with kit lot 353 and the result was high. A new blood draw from the same patient was run on the same instrument using kit lot 357 and the result was lower. The sample was repeated again on a different date (unknown if it was the initial sample or the sample from the new blood draw, or another new blood draw) on the same immulite 2000 instrument and the result was lower. The tg kit lot used to re-run the sample was not provided. The lower results were questioned by the physician(s). All the results were reported to the physician(s). It is unknown which of the results is the expected result on the patient sample. There are no known reports of patient intervention or adverse health consequences to the patient due to the discordant thyroglobulin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00186 |
| MDR Report Key | 7469716 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-27 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-05-24 |
| Date Added to Maude | 2018-04-27 |
| 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 | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT, LIMITED |
| Manufacturer Street | REGISTRATION # 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, GWYNEED LL55 4EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 THYROGLOBULIN |
| Generic Name | IMMULITE 2000 THYROGLOBULIN |
| Product Code | MSW |
| Date Received | 2018-04-27 |
| Catalog Number | L2KTY |
| Lot Number | 357 |
| 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 PRODUCTS, LIMITED |
| Manufacturer Address | GLYN RHONWY LLANBERIS, GWYNEDD LL55 4EL UK 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-27 |