MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-21 for IMMULITE 2000 THYROGLOBULIN manufactured by Siemens Healthcare Diagnostics Products Limited.
[50964565]
The cause of the failed slopes for the tg assay on the immulite 2000 instrument is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[50964566]
The customer has indicated that they are obtaining failed slopes for the thyroglobulin assay (tg) on the immulite 2000 instrument. A new reagent lot was shipped to the customer site, but the tg slopes continued to fail. Patient samples were not run or reported due to the slope failure on the instrument. The customer has a reported a delay in reporting patient results due to the high slopes on the immulite 2000 instrument. There were no reports of patient intervention or adverse health consequences due to the failed adjustment slopes for the tg assay.
Patient Sequence No: 1, Text Type: D, B5
[55339299]
The initial mdr 2432235-2016-00387 was filed on july 21, 2016. Additional information (08/08/2016): on (b)(6) 2016, the customer received reagent kit 336, which was kept at the room temperature overnight prior to being refrigerated. The operator performed a slope adjustment on this reagent kit and it failed. The operator repeated the slope adjustment with a fresh adjustor, and the slope failed again. The slope adjustment passed on the third attempt. Quality controls were within acceptable ranges. The customer stated that no patient care was affected due to delay in reporting of patient results. The patient sample results were within expectations. As per immulite 2000 thyroglobulin instructions for use, reagents should be stored at 2-8 degree celsius. The cause of the failed adjustment slopes for the thyroglobulin assay on immulite 2000 instrument is unknown. Corrected information (09/01/2016): (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00387 |
| MDR Report Key | 5811891 |
| Date Received | 2016-07-21 |
| Date of Report | 2016-09-01 |
| Date of Event | 2015-06-08 |
| Date Mfgr Received | 2016-08-08 |
| Date Added to Maude | 2016-07-21 |
| 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 PRODUCTS LIMITED |
| Manufacturer Street | GLYN RHOWNY, LLANBERIS GWYNESS, CAERNARFON |
| Manufacturer City | WALES, LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 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 | 2016-07-21 |
| Model Number | IMMULITE 2000 THYROGLOBULIN |
| Lot Number | 334, 337 |
| 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 RHOWNY LLANBERIS, CAERNARFON GWYNEDD, WALES, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-21 |