MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-02-09 for IMMULITE 2000 THYROGLOBULIN L2KTY2 manufactured by Siemens Healthcare Diagnostics Products Ltd..
[2536994]
Discordant high thyroglobulin (tg) results were obtained with two (2) samples (from the same patient) on an immulite 2000 xpi analyzer. The patient's two samples were initially tested on the immulite 2000 xpi analyzer. The laboratory questioned the initial tg results as "implausible" due to the patient's clinical history. The second sample was retested with a ria method, and the repeat result was reported out. There were no known reports of patient treatment being altered or prescribed due to the discordant tg results. There were no known no reports of adverse health consequences due to the discordant tg results.
Patient Sequence No: 1, Text Type: D, B5
[9588447]
The customer contacted the siemens healthcare technical solutions center (tsc) regarding the discordant high tg patient sample results. Siemens obtained the patient sample, and the discordant patient sample results were confirmed by siemens in-house testing. The cause of the discordant tg results is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00029 |
| MDR Report Key | 2444748 |
| Report Source | 05,06,07 |
| Date Received | 2012-02-09 |
| Date of Report | 2012-01-24 |
| Date of Event | 2011-11-09 |
| Date Mfgr Received | 2012-01-24 |
| Date Added to Maude | 2012-08-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | GLYN RHONWY LLANBERIS |
| Manufacturer City | GWYNEDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 THYROGLOBULIN |
| Generic Name | THYROGLOBULIN ASSAY |
| Product Code | MSW |
| Date Received | 2012-02-09 |
| Catalog Number | L2KTY2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD. |
| Manufacturer Address | GLYN RHONWY LLANBERIS GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-09 |