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 2019-05-10 for ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR 04388780190 manufactured by Roche Diagnostics.
[144685305]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[144685306]
The initial reporter stated that they received discrepant results for one patient sample tested with the elecsys anti-tshr immunoassay on a cobas 8000 e 602 module. An incorrect value was not reported outside of the laboratory. The event involved two analyzer lines. Line one contains two e 602 analyzers, serial numbers (b)(4). Line two contains two e 602 analyzers, serial numbers (b)(4). It is not known which of the two e 602 analyzers from each line was used for testing. The sample was tested on line two, resulting with an anti-tshr value of 2. 4 iu/l. The sample was repeated on line one, resulting with a value of < 0. 7 iu/ml. The sample was then re-centrifuged and repeated on both lines. When repeated on line two, it resulted with an anti-tshr value of 2. 5 iu/l. When repeated on line one, the value was < 0. 7 iu/l. A value of < 0. 7 iu/l was reported to a physician. No adverse events were alleged to have occurred with the patient. Calibration was performed on line two on (b)(6) 2019 and the signal value was higher than normal, but there were no calibration errors. Controls were within range on line two prior to the event. When testing controls on line two after the event, one level of control was outside of range. The assay was re-calibrated and controls were then repeated. Controls were then within range. An issue with assay calibration was suspected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01758 |
| MDR Report Key | 8599139 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-30 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-04-22 |
| Date Added to Maude | 2019-05-10 |
| 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 | 2019-05-10 |
| Model Number | NA |
| Catalog Number | 04388780190 |
| Lot Number | 373066 |
| Device Expiration Date | 2019-11-30 |
| 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 | 2019-05-10 |