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 2019-01-08 for ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR 07026951190 manufactured by Roche Diagnostics.
[132414278]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[132414279]
The customer complained of qc and calibration issues when testing elecsys anti-tshr (anti-tshr) on a cobas e801 module. The customer installed the anti-tshr reagent on (b)(6) 2018. There were no qc issues between (b)(6) 2018 and (b)(6) 2018. The customer began to run routine patient samples on (b)(6) 2018. The customer received qc data flags on (b)(6) 2018 on channel 2 of the instrument and started to only use channel 1 for patient results. On (b)(6) 2018 the customer received qc data flags on channel 1 and not channel 2. The customer attempted to re-calibrate; however, the calibration failed. Since there were no qc issues with channel 2, the customer used channel 2 for patient results. The customer contacted the sales representative who advised the customer to repeat the patient samples on a different e801 module. Upon repeat testing, discrepant high anti-tshr results were identified for 8 patient samples. The initial high results had been reported outside of the laboratory. There was no allegation that an adverse event occurred. The e801 module serial number was (b)(4). The field service engineer (fse) visited the customer site where no instrument issues were identified. The anti-tshr reagent has been used up and is no longer available. The fse performed reproducibility tests with the newly prepared reagents on both channel 1 and channel 2 of the instrument and there were no issues. During a review of the alarm trace data, no instrument issues were identified. Instrument check results were within specification. Based on the data available, the incorrect results were generated using an old calibration from (b)(6) 2018. Daily calibration is recommended for anti-tshr. If results using an incorrect calibration are compared to results from another system with correctly calibrated reagent, differences are expected. Investigations are ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00092 |
| MDR Report Key | 8226462 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-08 |
| Date of Report | 2019-03-12 |
| Date of Event | 2018-12-15 |
| Date Mfgr Received | 2018-12-15 |
| Date Added to Maude | 2019-01-08 |
| 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 | 2019-01-08 |
| Model Number | NA |
| Catalog Number | 07026951190 |
| Lot Number | 322386 |
| Device Expiration Date | 2019-03-31 |
| 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 | 2019-01-08 |