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 2018-06-01 for ELECSYS FERRITIN manufactured by Roche Diagnostics.
[110119780]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[110119782]
The customer stated that they received erroneous results for five samples from the same patient tested for multiple assays on a cobas 6000 e 601 module (e601) analyzer. Affected assays include the elecsys ft4 ii assay (ft4ii), the elecsys ft4 iii assay (ft4iii), elecsys ft3 iii (ft3), the elecsys tsh assay (tsh), elecsys ferritin (ferr), roche diagnostics elecsys anti-tg (anti-tg), roche diagnostics cobas elecsys anti-tpo (anti-tpo), and the elecsys anti-tshr immunoassay (anti-tshr). Patient identifiers for information related to each affected assay: (b)(6). The patient had "perfect" thyroid values in (b)(6) 2018. On (b)(6) 2018, the patient was hospitalized due to recurrent falling and general malaise. The 5 samples were collected from the patient and based on vastly increased ft4, ft3, and anti-tshr results, it was concluded that an initial attack of graves' disease occurred. The results for all thyroid assays did not fit the clinical picture of the patient, however, treatment for hyperthyroidism (strumasol) was started. Refer to attachment 1 for data from the five complained samples. Samples dated (b)(6) 2018 (sample 2), (b)(6) 2018 (sample 4), and (b)(6) 2018 (sample 5) were also tested on an abbott architect analyzer. In addition, the customer ran a comparison of the ft4ii and ft4iii assays on (b)(6) 2018 using samples dated (b)(6) 2018 (sample 1), (b)(6) 2018 (sample 2), and (b)(6) 2018 (sample 3). Unless otherwise indicated on attachment 1, the erroneous test results were reported outside of the laboratory. No adverse events were alleged to have occurred with the patient. The lot numbers and expiration dates of all involved reagents were asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01697 |
| MDR Report Key | 7561957 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-01 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-04-23 |
| Date Mfgr Received | 2018-05-08 |
| Date Added to Maude | 2018-06-01 |
| 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 | ELECSYS FERRITIN |
| Generic Name | RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN22 |
| Product Code | JMG |
| Date Received | 2018-06-01 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | NA |
| 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 | 2018-06-01 |