MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-02-08 for ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR manufactured by Roche Diagnostics.
[135719257]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[135719258]
The customer stated that they received erroneous results for one patient sample tested with the elecsys ft4 iii assay and roche diagnostics cobas elecsys anti-tpo on a cobas 6000 e 601 module. The same sample also had an erroneous result for the elecsys anti-tshr immunoassay on a cobas e 411 immunoassay analyzer. The erroneous values were reported outside of the laboratory and did not match the patient's clinical condition. This medwatch will apply to the anti-tshr assay. Please refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay and refer to the medwatch with patient identifier (b)(6) for information related to the anti-tpo assay. The sample was tested on the e 601 analyzer on (b)(6) 2019, resulting with a ft4 value of 31. 38 pmol/l and an anti-tpo value of 531 iu/ml. The sample was tested on the e 411 analyzer on (b)(6) 2019, resulting with an anti-tshr value of 6. 38 iu/l. The results from the roche analyzers did not agree with the clinical picture of the patient as the patient had a previous sample tested at another laboratory using the diasorin method and results were different. No adverse events were alleged to have occurred with the patient. The serial number of the customer's e 601 analyzer is (b)(4). The serial number of the customer's e411 analyzer was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00528 |
| MDR Report Key | 8320961 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-02-08 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-01-25 |
| Date Added to Maude | 2019-02-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR |
| Generic Name | ANTI-TSHR IMMUNOASSAY |
| Product Code | JZO |
| Date Received | 2019-02-08 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 361864 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-08 |