MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-16 for IMMULITE 2000 manufactured by Siemens Healthcare Diagnostics Inc..
[70418343]
A siemens headquarters support center (hsc) specialist reviewed the adjustment and quality control data provided by the customer and determined that the adjustments and quality control recoveries were in range. The cause of the discordant thyroglobulin results is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[70418344]
Discordant thyroglobulin results were obtained on three patient samples on an immulite 2000 instrument, while using reagent lot 338. The initial and repeat results were obtained on the same instrument with the same reagent lot. It is unknown if any of the results were reported to physician(s). There are no known reports of patient intervention due to the discordant thyroglobulin results. There are no known reports of a delay in administering treatment or medical intervention to patients due to the discordant thyroglobulin results.
Patient Sequence No: 1, Text Type: D, B5
[75939877]
The initial mdr 2247117-2017-00033 was filed on march 16th 2017. Additional information (04/24/2017): a siemens headquarter support center (hsc) specialist reviewed the instrument logs, adjustment data and quality control data associated with the discordant results of the three patient samples. There was no indication of an issue with the adjustment of the thyroglobulin (tg) assay. Data review of the instrument support files did not indicate any mechanical factors that could have contributed to the discordant results. With respect to the quality control data associated with each of the discordant results: (b)(6) - discordant result generated on (b)(6) 2016. Review of quality control (qc) data for (b)(6) 2016 indicates that qc was performed with level 1 and was in range. (b)(6) - discordant result generated on (b)(6) 2016. Review of qc data for (b)(6) 2016 indicates that qc was performed with levels 1 and 2 and both levels were high out of range with no repeats observed. (b)(6) - discordant result generated on (b)(6) 2016. Review of qc data indicates that qc was performed with levels 1 and 3 and level 3 was high out of range with no repeats observed. Review of the results of a precision study performed by the customer with thyroglobulin reagent lot 346 indicates that the assay precision with this current reagent lot is within specifications. The cause of the discordant thyroglobulin results is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2017-00033 |
| MDR Report Key | 6409456 |
| Date Received | 2017-03-16 |
| Date of Report | 2017-10-23 |
| Date of Event | 2016-11-11 |
| Date Mfgr Received | 2017-09-28 |
| Date Added to Maude | 2017-03-16 |
| 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 | DEVYANI CHAUDHURI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242637 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY ROAD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMULITE 2000 |
| Product Code | MSW |
| Date Received | 2017-03-16 |
| Model Number | IMMULITE 2000 |
| 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 | 62 FLANDERS BARTLEY RD. FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-16 |